Methods of taking therapeutic measures or supporting therapeutic treatment actions

Abstract

The present invention relates to support for taking therapeutic treatment or performing therapeutic treatment acts on individual Ii, a system for implementing the same, and a computer program product.

Description

Technology Field

[0001] The present invention relates to individual I i It relates to support for taking therapeutic treatment or performing therapeutic treatment actions, and to systems and computer program products for implementing this. Background Technology

[0002] The term "taking therapeutic treatment" or "performing a therapeutic treatment act" in the sense of the present invention refers to an individual I facing a disease in order to treat the disease, alleviate symptoms, or prevent the onset of the disease. i A series of actions prescribed by a medical professional to individual I i It means performing by.

[0003] More specifically, taking therapeutic measures may involve taking active substances, such as curative, palliative, or preventive drugs. Insofar as the effect and / or effectiveness of the active substance can be measured, the intake of active substances, such as foods, nutrients, oligo elements, carbohydrates, and vitamins, may also be considered.

[0004] More specifically, a therapeutic treatment act may be a physical act, a physiological act, or the use of a medical device similarly related to the administration of a drug, provided that the effect and / or validity of such act or use is measurable. An example of a therapeutic act may be exposure to light within the scope of phototherapy, for example in the case of a skin lesion, provided that the melanin ratio and the size of the skin lesion can be monitored to measure the validity or effect of the treatment.

[0005] Taking medication means, for example, taking insulin in the treatment of diabetes, and its effect can be monitored by measuring blood glucose levels.

[0006] Taking food, nutrients, oligo elements, carbohydrates, and vitamins means, for example, taking iron in the treatment of anemia, and the effect can be monitored by measuring the blood hemoglobin ratio.

[0007] Recently, there has been increasing interest in patient adherence to treatment dosing regimens. The treatment dosing regimen prescribed to patients, also known as posology, is defined by both the recommended dose and the frequency of administration or administration.

[0008] When receiving treatment, it is known that in the case of drugs, foods, nutrients, oligourea, carbohydrates, and vitamins, the active ingredient(s) are absorbed, distributed, metabolized, and eliminated by the patient, and the concentration of the active ingredient(s) (plasma, saliva, urine, tissues, blood, capillaries, etc.) increases and decreases over time as treatment is received continuously.

[0009] The administration regimen generally aims to maintain the concentration of the active ingredient(s) (in plasma, saliva, urine, tissue, blood, capillaries, etc.) within a treatment interval, also known as the therapeutic window, that is, within a range of concentrations of the active ingredient(s) that ensures optimal therapeutic, remission, or prevention effects while minimizing the risk of side effects. The administration regimen aims not to fall below the minimum concentration corresponding to underdosing in patients, which may result in an increased risk of failure of treatment or prevention, and aims not to exceed the maximum concentration of the active ingredient corresponding to overdosing in patients, which may result in a risk of toxicity.

[0010] Furthermore, in certain cases, the administration regimen aims to maintain very high concentrations of the active ingredient(s) (in plasma, saliva, urine, tissues, blood, capillaries, etc.) for a short period, i.e., at a peak, and to group the side effects experienced by the patient over a more limited time, or to have a decisive effect on the body, such as by blocking specific transmitters or inhibitors.

[0011] Therefore, the therapeutic window may vary over time, particularly to reach a transient peak of high concentration or a rest period after each treatment cycle.

[0012] It is estimated that more than 50% of patients do not adhere to or barely adhere to their treatment, leading to recurring problems of underdose and overdose. These figures increase as patients often take multiple drugs with different dosage regimens due to a combination of population aging, the global increase in the number of chronic diseases, and multi-morbidities in the same patient.

[0013] In the case of treatment involving one or more therapeutic actions, the effect of the treatment may change over time depending on the method of action.

[0014] The frequency of therapeutic actions aims to maintain the effectiveness of the treatment within a window of treatment efficacy, such as between underexposure to actions that make the treatment ineffective and overexposure to actions that potentially make the treatment dangerous.

[0015] It is important for the patient to be able to experience the effects of therapeutic treatment. In fact, for each of the actions taken or performed as a therapeutic treatment, there are directly identifiable related effects for the patient, such as the sensation of pain, or related effects that are not directly identifiable, such as the concentration of the active substance of the therapeutic treatment.

[0016] The effects associated with taking a therapeutic treatment or performing a therapeutic treatment, respectively, can be measured and / or identified by measurable or corrected therapeutic effects, such as concentrations (plasma, saliva, urine, tissue, blood, capillaries, etc.), biomarkers, and, for example, corrections to pain thresholds.

[0017] For example, when a patient is treated by phototherapy, the directly identifiable related effect for the patient is an improvement in their mood or a reduction in skin lesions. In the case of skin lesions, a related effect that is not directly accessible to the patient is the regulation of the amount of melanin in the body following the therapeutic treatment by phototherapy. In the case of mood improvement, a related effect that is not directly accessible to the patient is the regulation of the amount of melatonin in the body following the therapeutic treatment by phototherapy.

[0018] In addition, when a patient is treated with a pain-relieving therapeutic treatment, the patient's directly identifiable related effect is a reduction in their pain, and thus the latter can be corrected according to a pain threshold. Additionally, a related effect that the patient cannot directly access is an increase in the amount of active substance that enables the suppression of pain in the body after the therapeutic treatment.

[0019] By therapeutic adherence, this is, in the sense of the present invention, on the one hand, persistence that enables defining the duration while the patient continues to receive their treatment, and on the other hand, implementation that enables characterizing the manner in which the persistent patient administers their treatment daily.

[0020] For example, a patient may follow their treatment regularly without omission, that is, at maximum execution. However, the patient may omit administration, delay / prepare administration, administer additional doses, or discontinue their treatment early, in which case this corresponds to non-persistence.

[0021] Furthermore, for example, in the case of chronic diseases, patients receive their treatment for several years; that is, they are continuous with their treatment. However, considering the patients' daily lives, they allow themselves to practice less than optimally—that is, whether intentionally or not, stagger their treatment schedule in relation to dosage regimens, missed treatments, missed consecutive treatments, or periods of treatment-free periods corresponding to therapeutic breaks.

[0022] In addition, patients may not follow the dosage regimen in terms of administration because they take only a portion of the dose provided by the treatment or take a larger dose than provided by the treatment.

[0023] Furthermore, therapeutic adherence is influenced by numerous parameters, such as those cited in the following article: Adhesion therapeutique du patient chronique: des concepts a la prise en charge ambulatoire (Therapeutic adherence of the chronic patient: concepts in outpatient management), Rev Med Suisse 2013; volume 9. 1032-1036:

[0024] - Sense of individual validity,

[0025] - Knowledge and understanding of the risks of the disease,

[0026] - Patients' expectations regarding treatment,

[0027] - Perceived benefits of treatment,

[0028] - Barriers and facilitators.

[0029] In any case, theoretically, the benefits of optimal therapeutic adherence to therapeutic, palliative, or preventive treatments appear clear not only for the health of the individual and the patient but also for maintaining the economic balance of healthcare.

[0030] In reality, it is easy to think that respecting the administration regimen for a patient depends on numerous factors, whether intentional or not.

[0031] Furthermore, it is easy to observe and identify that patients are not robots leading ordinary daily lives where the same things are repeated every day. On the contrary, patients are exposed to numerous "life events," such as the need for sleep, meals, and professional or non-professional activities. Moreover, when obstacles such as side effects occur, a patient's reluctance to take prescribed therapeutic measures may delay either taking therapeutic measures for comfort or performing the therapeutic act, in order to experience the side effects at a more appropriate place or time than elsewhere. This is also more reasonable considering that patients are sick individuals, sometimes in the range of difficult treatments, and that all patients are more vulnerable to "life events," such as needing to rest or avoiding side effects to provide them with some comfort.

[0032] Furthermore, numerous individuals struggle to establish a method of taking, particularly in cases involving cognitive problems.

[0033] Patients undergoing treatment frequently deviate from their prescribed regimen, not only in routine practice but also in the case of therapeutic treatments tested during clinical studies. More specifically, for treatments with a narrow therapeutic window, such as anti-rejection treatments or anticoagulants, it is important to take the medication at regular intervals, including remembering the time elapsed since the previous dose, and the regularity of medication intake is a key factor in treatment success. Additionally, there are many reminder devices that theoretically help patients remember that they must take their therapeutic treatment.

[0034] However, it is important to be able to identify a causal relationship between the irregularity of taking or performing therapeutic measures and, for example, the success of treatment or the occurrence of side effects. Therefore, the identified causal relationship should enable whether the patient is suited to the dosage regimen in the case of treatment, or whether the dosage regimen to be prescribed when the drug under study is released to the market is effective, or whether it is effective in modifying the patient's behavior.

[0035] There is a device that provides a level of compliance with prescribed treatment and helps with receiving treatment. Brief explanation of the drawing

[0036] The present invention will now be described in more detail with reference to the accompanying drawings. FIG. 1 illustrates a system intended to support taking a therapeutic treatment or performing a therapeutic treatment act according to the present invention. FIG. 2 illustrates a theoretically predicted pharmacokinetic model for a "robot" entity. FIG. 3 illustrates a modified pharmacokinetic model for an entity considering the history of receiving treatment or performing a therapeutic act. FIG. 4 illustrates an individualized pharmacokinetic model for an entity adapted to a "weekend" type event. FIG. 5a and 5b illustrate an individualized pharmacokinetic model for an entity adapted to a "high variability" type event. FIG. 6a, 6b, and 6c illustrate an individualized pharmacokinetic model for an entity including the time interval Tmin and buffer Tmin for the next dose and the time interval Tmax and buffer Tmax before the next dose. FIG. 7a and 7b illustrate a theoretically predicted pharmacodynamic model for a "robot" entity. Figures 8a and 8b show a modified predicted pharmacodynamic model for an object considering the history of receiving treatment or performing therapeutic acts. Figures 9a through 9e show examples of time gauges representing positioning data of an object in a target window for taking therapeutic treatment or performing therapeutic treatment acts. Specific details for implementing the invention

[0037] The present invention falls within this context, and individual I i A method for supporting taking therapeutic treatment for or performing therapeutic treatment acts, comprising the following steps:

[0038] - A step of obtaining therapeutic treatment data, such as a series of pharmacometrics models for at least one predetermined indication and a target window for each predetermined treatment, from a database by a first device;

[0039] - Object I comprising the following, by the first device i Step to acquire specific data of:

[0040] a) Individual I selected from a group consisting of dosing, posology, and the time theoretically required to receive each prescribed therapeutic treatment i Variable data of;

[0041] - By the first device, the series of pharmacological models and the entity I i Object I from the variable data of i Step to calculate the expected data model.

[0042] The purpose of document WO2015 / 006033 is a method for assisting with dosage selection for a given individual.

[0043] In the method described above, the system obtains a pharmacokinetic model of the drug and a target window for treatment, more specifically a therapeutic window, through a pharmacological model, more specifically a method of treatment.

[0044] Therefore, based on specific data (variable data of the individual, variable data of the prescribed dosage, variable data of the prescribed dosage regimen, theoretical time for receiving treatment) from the set of pharmacokinetic profiles of the patient samples, the medical staff [referenced] individual I i Choose the one closest to it.

[0045] The method according to this literature is intended for medical personnel such as physicians, and through this method, physicians [determine] dosage and administration intervals and individual I iThe minimum allowable concentration of plasma proteins can be adjusted. In practice, the method according to this literature applies to patients, i.e., individuals I who are unlikely to be directly managed by medical intervention without affecting their therapeutic treatment. i It is not for.

[0046] US2004 / 193446 describes the monitoring of an object by an electronic device for the purpose of taking medication. The electronic device sends a signal to the object when the object forgets to take their medication.

[0047] Unfortunately, current devices provide expected static information regarding past effects that account for the efficacy of the therapeutic treatment performed; this information is based on theoretical behaviors, such as those prescribed by medical professionals, and is, for example, a model based on a prescription modified with patient information and parameters. Furthermore, current devices provide information to medical staff to redefine better dosage regimens suitable for the patient.

[0048] Therefore, this model sometimes does not align with reality, and in practice, it is impossible to reconfigure a model based on blood concentration measurements obtained from patients. This model cannot make the concentration data calculated by the model match observed / measured concentrations, even after corrections obtained through model translation, as it does not account for concentration variability due to imperfect adherence.

[0049] It is necessary to provide a device that not only provides information about the present or future at each moment t, considering the life events of a given individual, but also provides information about the patient's conscientiousness regarding the results of deviations in the patient's involvement and dosing regimen, as well as improvement in the regularity of treatment, i.e., the patient's therapeutic compliance.

[0050] The present invention is characterized by further comprising the following steps, as mentioned in the introduction, object I i The purpose is to solve the aforementioned problem by providing a first method for supporting taking therapeutic treatment or performing therapeutic treatment actions regarding:

[0051] - A step of obtaining from a database by a first device a series of pharmacometrics models for at least one predetermined indication, and a data model of a therapeutic treatment, such as a target window for a therapeutic treatment;

[0052] - By electronic monitoring device, in particular, Object I i Object I, including its time stamping i a step of recording indication data associated with taking the above-mentioned therapeutic treatment or performing the therapeutic treatment act;

[0053] - By the first device, object I i A step of receiving the aforementioned indication data from an electronic monitoring device that is associated with taking the aforementioned therapeutic treatment or performing the therapeutic treatment act;

[0054] - By the first device, the entity I from the data model of the therapeutic treatment and from the indication data associated with taking the therapeutic treatment or performing the therapeutic treatment act i Step of calculating the modified data model of;

[0055] - The above entity I i Object I in the target window of the predetermined therapeutic treatment by the first device from the above modified model of iA step of calculating positioning data and indicator data of taking the therapeutic treatment or performing the therapeutic treatment act, and / or a step of calculating and / or indicating time information for taking the therapeutic treatment next or performing the therapeutic treatment act next by the first device.

[0056] Object I in the target window of the above therapeutic treatment i Time information regarding the positioning of or the next taking of the above therapeutic treatment or the next action of the above therapeutic treatment enables the individual to better plan the next taking of the therapeutic treatment or the next action of the therapeutic treatment, which makes compliance with the therapeutic treatment simpler and more flexible, and consequently makes it more effective.

[0057] The present invention is further characterized by comprising the following steps, as mentioned in the introduction, object I i The purpose is to solve the aforementioned problem by providing a second method for supporting taking therapeutic treatment for or performing therapeutic treatment actions:

[0058] - A step of receiving from an electronic monitoring device, by means of a first device, indication data associated with taking a predetermined therapeutic treatment or performing a therapeutic treatment act, including, in particular, a time stamp, a dosage, and a history of taking a therapeutic treatment or performing a therapeutic treatment act;

[0059] - By the first device, object I i Entity I from the above-mentioned expected data model and the above-mentioned indication data associated with taking the above-mentioned predetermined therapeutic treatment or performing the therapeutic treatment act i Step of calculating the modified data model of;

[0060] - By the first device, at each moment t, object I i Entity I from the above modified data model and the above indication data associated with taking the above predetermined therapeutic treatment or performing the therapeutic treatment act i A step of calculating an individualized data model, wherein the individualized model comprises the value of the effect at each moment t, and entity I i A calculating step comprising: the whole or part of the value of taking a predetermined prior therapeutic treatment or performing a prior therapeutic treatment act, the time stamp of taking the therapeutic treatment or performing the therapeutic treatment act, and considering taking the prior therapeutic treatment or performing the prior therapeutic treatment act;

[0061] - By the first device, object I i Object I in the target window of the aforementioned specific therapeutic treatment from the above individualized model i A step of calculating positioning data and indication data of taking the therapeutic treatment or performing the therapeutic treatment act, wherein the target window includes a minimum and / or maximum threshold, e.g., a predetermined efficacy loss threshold and / or a predetermined toxicity threshold.

[0062] According to the present invention, the method transforms historical statistics to explain differences in therapeutic effects for pharmacokinetic models of the prior art and considers differences in prescribed dosage regimens / therapy. Indeed, individual I i The individualized model corresponds to reality because it considers indication data associated with taking or performing said therapeutic treatment, including timestamps, actual or assumed dosages, and a history of taking or performing the therapeutic treatment, and also Entity I i Consider the value of the residual content of a predetermined therapeutic treatment for.

[0063] According to the present invention, a database comprises a series of pharmacological models for at least one predetermined indication (e.g., pharmacokinetic and / or pharmacodynamic and / or pharmacoeconomic and / or any other available pharmacological models), and target windows for each predetermined therapeutic treatment stored and recorded in the database (e.g., therapeutic window and / or efficacy threshold to be reached and / or toxicity threshold not to be exceeded and / or cost / benefit window and / or any other target window, and the target window may vary over time), and possibly individual I i The parameters of can be recorded in the database, and possibly object I i The concentration data of can be recorded in a database, and more specifically, object I i Variable data can be recorded in the database.

[0064] In addition, the method according to the present invention comprises, by means of a first device, an individual I selected from a physiological group (e.g., body weight, age, sex) of a genetic marker and a biological marker. i Subject I including parameters of the pharmacological model for i It includes a step of obtaining specific data of.

[0065] The method according to the present invention comprises, by means of a first device, an individual I selected from the group of measured effect of treatment, measured concentration, side effects, expected half-life, expected duration of action, and cost / effectiveness ratio. i Object I including medical data i It further includes a step of obtaining specific data of.

[0066] The method according to the present invention, by means of a first device, object I i Object I of the expected data modeli Object I of the modified data model i Object I of the individualized data model i Pharmacological model for and / or the above entity I i It further includes a step of calculating from the parameters of the medical data.

[0067] Actually, the first device according to the present invention is object I i Parameters of the pharmacological model for and / or object I i It is particularly advantageous that by acquiring medical data, it is possible to calculate an expected data model, a modified data model, or an individualized data model approaching reality. In fact, the first device according to the present invention [individualizes] object I i The more specific data of is acquired, the more entity I i The expected data model, modified data model, or individualized data model will be more accurate and complete.

[0068] Additionally, the first device may include one or more databases. In practice, for each specific therapeutic treatment, it may include a first database containing therapeutic treatment data such as a series of pharmacological models, for example, pharmacokinetics and / or pharmacodynamics and / or pharmacoeconomics for at least one specific indication, and a target window (which may change over time).

[0069] The first device is the following object I i It may include a second database containing specific data of: a) an individual I selected from a physiological group of genetic markers or biological markers (e.g., weight, age, sex). i Parameters of the pharmacological model for; b) measured effect of treatment, measured concentration, side effects, expected half-life, expected duration of action, cost / effectiveness ratio; subject I selected from the group imedical data of; and c) dosage, dosage regimen, and individual I selected from the time group theoretically receiving each specified therapeutic treatment. i Variable data of.

[0070] The first device comprises data of a therapeutic treatment, such as a series of pharmacological models, e.g., pharmacokinetic and / or pharmacodynamic and / or pharmacoeconomic models for at least one specified indication, and data of a therapeutic treatment, such as a target window for each of the specified therapeutic treatments, and the following entity I i It may include a third database containing all specific data of: a) an individual I selected from a physiological group of genetic markers or biological markers (e.g., weight, age, sex). i Parameters of the pharmacological model for; b) Subject I selected from the group of measured effect of treatment, measured concentration, side effects, expected half-life, expected duration of action, and cost-effectiveness ratio i medical data of; and c) dosage, dosage regimen, and individual I selected from the group of times for theoretically receiving each specified therapeutic treatment. i Variable data of.

[0071] According to the present invention, a first device receives from an electronic monitoring device indication data associated with taking a predetermined therapeutic treatment or performing a therapeutic treatment act, and such indication data includes, in particular, a timestamp, for example, an actual or assumed dosage, and a history of receiving treatment or performing a therapeutic act.

[0072] Then the first device is object I i From the expected data model of and indication data associated with taking therapeutic treatment, entity I representing the effect of therapeutic treatment on the patient over time iCalculate the modified data model of assimilation, distribution, metabolism and / or elimination and / or the measured effect and / or measured concentration of treatment and / or side effects and / or expected half-life and / or subject I i Medical data related to the expected duration of action is considered, and the date, time, dosage, taking or performing therapeutic treatment, and the history of taking or performing therapeutic treatment are also considered.

[0073] Object I i The calculation of the modified data model makes it possible to provide a model that takes into account the differences from the existing pharmacological model and the differences between taking therapeutic treatment or performing therapeutic treatment actions for prescribed treatment, and takes into account the history of taking actual therapeutic treatment or performing actual therapeutic treatment actions.

[0074] In fact, using existing pharmacokinetic models of the prior art, the peaks or troughs of the measured therapeutic effect can be explained solely by changes in the patient's pharmacokinetic parameters, e.g., absorption, distribution, metabolism, and / or elimination.

[0075] According to the present invention, when a peak of therapeutic effect is observed in a model, for example, if the peak of the concentration of the active substance of a therapeutic treatment coincides with an event of taking the therapeutic treatment or performing the therapeutic act, it can be explained as a result of receiving the treatment or performing the therapeutic act, rather than due to rapid assimilation. When a trough of therapeutic effect in a model, for example, a trough of concentration coincides with the absence of an event of taking the therapeutic treatment or performing the therapeutic act for a certain period, it can be explained by the omission of taking the therapeutic treatment or performing the therapeutic act, rather than rapid elimination.

[0076] Consequently, because the subject's modified data model considers indication data associated with taking therapeutic treatment, it enables the explanation of differences and does not attribute changes in effect to incorrect causes.

[0077] Consequently, differences in therapeutic effects or side effects of therapeutic effects can be directly attributed to physiological problems associated with the patient, such as changes in absorption, distribution, metabolism, or elimination, or issues related to therapeutic treatment, as well as problems with the patient's therapeutic compliance.

[0078] The electronic monitoring device includes a power supply, a sensor, a processor, a communication unit, a clock, and memory. The above elements may be contained in one or more electronic devices. Object I i Whether the sensor of the electronic monitoring device operates automatically when A performs a therapeutic treatment or acts of therapeutic treatment, for example, in the case of a push button, Object I regarding the sensor i The action is recorded as an event of taking a therapeutic treatment or performing a therapeutic treatment. The processor is configured to process the event of taking a therapeutic treatment or performing a therapeutic treatment and to generate a signal containing indicator data associated with taking a therapeutic treatment or performing a therapeutic treatment. This indicator data includes a timestamp, an actual or assumed dose, and a history of taking a therapeutic treatment or performing a therapeutic treatment. In practice, the processor records the indicator data associated with taking a therapeutic treatment or performing a therapeutic treatment in the memory of the electronic monitoring device, and also records the indicator data associated with the action of the therapeutic treatment of the drug or the distributor.

[0079] By means of an electronic monitoring device, in the sense of the present invention, this means, for example, packaging, a case, a drug container, an embedded (or non-embedded) distributor including an electronic monitoring device, and also means packaging, a case, a drug container, an embedded (or non-embedded) distributor connected via a smartphone app, a tablet, or a smartwatch, or other electronic recording device arranged to generate a signal including indication data associated with taking a therapeutic treatment or performing a therapeutic treatment act. It also means any other recording means capable of declaring, for example, registering that a patient has performed their own therapeutic treatment or therapeutic treatment act.

[0080] According to the present invention, the first device, at each moment t, present or future, object I i Based on the modified data model of and indication data associated with taking therapeutic treatment or performing therapeutic treatment actions, Entity I i Calculate the individualized data model of.

[0081] In fact, according to the present invention, object I i The individualized data model of is the value of the effect at each moment t, entity I i Considering all or part of taking a predetermined prior therapeutic treatment or performing a prior therapeutic treatment act, i.e., the proportion of the therapeutic treatment, for example, the proportion of the active substance of the therapeutic treatment for the individual that has not yet been removed. Based on a modified data model of the individual that considers the values ​​of the residual intensity and dosage of taking the prior therapeutic treatment or performing the prior therapeutic treatment act, the first device according to the present invention, using indication data and timestamps associated with taking the therapeutic treatment or performing the therapeutic treatment act at each moment t, present or future, individual Ii Calculate the individualized data model of.

[0082] According to the present invention, the first device, based on an individualized model of an individual and indication data associated with taking a therapeutic treatment or performing a therapeutic treatment act, at each moment, in a target window of a predetermined therapeutic treatment, individual I i Calculate the positioning data of.

[0083] In practice, the first device makes it possible to predictively calculate changes in concentration over time and / or effects resulting from taking a therapeutic treatment or performing a therapeutic treatment act, which is the value of the effect at each moment t, individual I i Consider the presumption of taking a prescribed prior therapeutic treatment or performing a prior therapeutic treatment act for the purpose of... in whole or in part.

[0084] A target window that may change over time includes, at any time, a minimum and / or maximum threshold, e.g., a validity loss threshold and / or a toxicity threshold, both of which are specified.

[0085] Particularly advantageously, according to the present invention, for calculation, by a first device, object I in this target window (therapeutic window and / or efficacy threshold to be reached and / or toxicity threshold not exceeded and / or cost / benefit window and / or any other target window). i It appears possible to calculate the positioning data of. This positioning data is entity I i Considering the individualized model of and indication data associated with taking therapeutic treatment or performing therapeutic treatment behaviors, and while considering differences in therapeutic adherence, Subject I i This is due to individualized indication data associated with taking therapeutic treatment or performing therapeutic treatment actions.

[0086] In fact, the first device according to the present invention is advantageously given object I by implementing a method for supporting taking a therapeutic treatment or performing a therapeutic treatment act. i , makes it possible to make the patient conscious of the importance of the regularity of therapeutic treatment—that is, optimal therapeutic compliance by placing its therapeutic effect in the target window at each moment t, present or future. Therefore, individual I i At each moment t, present or future, it can identify the location of the toxicity threshold and / or the validity threshold and / or the cost / profit window or any other target window to reach.

[0087] The device according to the present invention also includes object I i This makes it possible to make patients conscious of the influence of therapeutic adherence on the therapeutic effect of treatment by specifying the therapeutic effect of their treatment at each moment, present or future, within the target window. In practice, it is important for patients to see the relationship between therapeutic adherence, therapeutic effect, and the effectiveness of the therapeutic treatment.

[0088] If this information is provided to a medical professional, patient, entity I i It can subsequently be identified that the patient faces problems with therapeutic adherence, rather than problems with assimilation, distribution, metabolism, and / or elimination. In this case, the solution is to avoid overdosing on therapeutic treatments, for example, drugs, and to educate the patient on good treatment adherence by understanding the causes of these behaviors at risk of increasing toxicity or altering the therapeutic treatment molecules.

[0089] In a preferred embodiment of the present invention, the method comprises, by means of a first device, object I in the target window of the predetermined therapeutic treatment iIt further includes the step of calculating the time interval Tmin to be observed before taking the next therapeutic treatment or performing the next therapeutic treatment action from the above positioning data.

[0090] In another preferred embodiment of the present invention, the method comprises, by means of a first device, object I in the target window of the predetermined therapeutic treatment i It further includes the step of calculating the time interval Tmax to be observed for taking the next therapeutic treatment or performing the next therapeutic treatment action from the above positioning data.

[0091] Particularly advantageously, calculating the time interval Tmin to be observed before taking the next therapeutic treatment and / or the time interval Tmax to be observed for taking the next therapeutic treatment by the first device appears to make it possible to provide patients with accurate and simple information to understand the future of their therapeutic regimen, namely, taking the next therapeutic treatment and the time interval between Tmin and Tmax at which the next therapeutic treatment action must occur.

[0092] By the first device, the calculation of the time interval Tmin to be observed before taking the next therapeutic treatment is patient, individual I i a, such as therapeutic effects, for example, individual I i Information can be provided regarding the minimum time prior to which therapeutic treatment or therapeutic treatment activities should not be performed so that the concentration of the active substance does not exceed a maximum threshold, for example, a predetermined toxicity threshold.

[0093] By the first device, the calculation of the time interval Tmax to be observed for taking the next therapeutic treatment is patient, individual I ia. Information can be provided regarding the maximum time prior to which therapeutic treatment or therapeutic treatment actions must be performed so that, for example, the concentration of an active substance in the body does not fall below a minimum threshold, for example, a predetermined efficacy loss threshold, such as a therapeutic effect.

[0094] In practice, in both cases, it is undesirable for the passage of therapeutic effect, e.g., the concentration of the active substance, to exceed the toxicity threshold or fall below the efficacy loss threshold, and by limiting the passage of the critical threshold as much as possible, individual I i Positioning the concentration of the active substance within the target window is important for the success of the therapeutic treatment.

[0095] Unlike providing information about the past or a score regarding the history of a patient's therapeutic adherence, according to the present invention, the first device provides the number of hours and / or minutes (whether a whole number or not) to be observed in the future:

[0096] - Therapeutic effects, for example, individual I i Taking the following therapeutic measures or performing the following therapeutic actions to ensure that the concentration of the active substance does not exceed a predetermined toxicity threshold or time interval Tmin,

[0097] - Therapeutic effects, for example, individual I i It is provided for taking the following therapeutic treatment or performing the following therapeutic treatment act so that the concentration of the active substance does not fall below a predetermined efficacy loss threshold, time interval Tmax.

[0098] Therefore, the method according to the present invention is individual I iOptimizes the effectiveness of their therapeutic treatment by supporting them and, in any case, guiding them to take future therapeutic treatment or perform future therapeutic treatment actions without providing them with a single indication of past effects in cases where it is too late to act.

[0099] For example, this allows patients treated with light therapy to see that their mood improves, for example, for 20, 18, 15, 12, 10, 8, 5, and 2 hours, before the body's melatonin ratio drops below the effective loss threshold and their mood deteriorates.

[0100] In addition, for patients being treated with a pain-relieving active substance, this allows us to know that the active substance remains with them, for example, for 5 hours, before the ratio of the pain-reducing active substance in the body drops below the efficacy loss threshold, and that their pain returns.

[0101] Advantageously, the method according to the present invention, by means of a first device, in the target window of the predetermined therapeutic regimen, object I i The method further includes the step of calculating at least one time interval "buffer Tmin" from the above positioning data before taking the next therapeutic treatment or performing the next therapeutic treatment act.

[0102] Advantageously, the method according to the present invention, by means of a first device, in the target window of the predetermined therapeutic treatment, individual I i The method further includes the step of calculating at least one time interval "buffer Tmax" for taking the next therapeutic treatment or performing the next therapeutic treatment act from the above positioning data.

[0103] Existing target windows, for example, therapeutic windows, include three regions, and therapeutic effects, for example, Subject I i The concentration of the active substance for includes an optimal zone, which is the extent to which the therapeutic treatment produces the desired, curative, palliative, and preventive effects; a toxicity zone limited to the optimal zone by a predetermined toxicity threshold; and a loss of efficacy zone separated from the optimal zone by a loss of efficacy threshold.

[0104] According to the present invention, it appears particularly advantageous to provide a therapeutic window having five regions, for example, including three prior regions, for example, a minimum buffer region of loss of efficacy, and for example, a maximum buffer region of toxicity.

[0105] Generally, an efficacy loss buffer region based on the concept (notion) of the forgiveness of a treatment makes it possible to predict the flow of therapeutic effects, such as the concentration of an active substance for an individual, in the efficacy loss region.

[0106] The toxicity buffer region allows for the prediction of the flow of therapeutic effects of the concentration of an active substance on an individual, for example, within the toxicity region.

[0107] According to the present invention, advantageously, the step of calculating the time interval buffer Tmin and / or the time interval buffer Tmax by the first device appears to enable providing patients with more flexibility and comfort in managing their therapeutic treatment.

[0108] In addition, the validity loss and toxicity buffer regions can be changed on the one hand, and dynamic on the other.

[0109] In practice, depending on the patient's perception, for example, patients who experience severe side effects after taking or performing therapeutic treatment may change the toxicity buffer area to reduce the sensation of side effects, either by self-decision or through a medical professional.

[0110] Furthermore, it is important to instill a habit of taking or performing therapeutic treatments in the patient, and for this purpose, a dynamic buffer zone is required. The goal is to start the patient with a narrow optimal zone—namely, a significant toxicity buffer zone and a significant loss of efficacy buffer zone—to help the patient develop a habit of taking or performing regular therapeutic treatments. Once the patient establishes a habit of taking or performing therapeutic treatments, the toxicity and loss of efficacy buffer zones can be reduced and limited, while the optimal zone expands, providing greater comfort and flexibility in the management of their therapeutic treatments.

[0111] In another embodiment, the method according to the present invention, by means of a first device, in the target window of the predetermined therapeutic treatment, object I i From the above positioning data, before receiving the next treatment or performing the next therapeutic act, at least one second time interval buffer Tmin and / or in the target window of the above predetermined therapeutic treatment, object I i The method further includes the step of calculating at least one second time interval buffer Tmax for receiving the next treatment or performing the next treatment action from the above positioning data.

[0112] Furthermore, a buffer zone exists regardless of the patient and includes the characteristics of the drug. This buffer zone can be adjusted by the patient or a healthcare professional, may be modified preventively or not, and enables taking measures in accordance with advice regarding taking therapeutic treatment or performing therapeutic actions provided by a healthcare professional.

[0113] Advantageously, object I in the above target window i The positioning data represents at least one piece of information selected from the group consisting of the following:

[0114] - Time of taking therapeutic treatment, time of performing previous therapeutic treatment actions,

[0115] - Object I i Response of a pharmacological model to a specific therapeutic treatment for

[0116] - Time, Tmax, before the response to a specific therapeutic treatment falls below the minimum threshold of the specified target window

[0117] - Time, Tmin, such that the response to a specific therapeutic treatment does not exceed the maximum threshold of a specific target window.

[0118] Advantageously, the positioning data further indicates at least one time interval buffer Tmax before the response to a given therapeutic treatment falls below the minimum buffer threshold of the target window.

[0119] Advantageously, the positioning data further indicates at least one time interval buffer Tmin such that the response of a given therapeutic treatment does not exceed the maximum buffer threshold of the target window.

[0120] In fact, it is positioning data representing the following:

[0121] The time of taking therapeutic measures and the time of previous therapeutic actions make it possible to provide the patient with an indication of their history of taking and performing therapeutic actions, and this is even more important for all patients who are sick, elderly, or suffering from memory impairment.

[0122] Object I i The effect of a specific therapeutic treatment makes it possible to provide the patient with a piece of information regarding their positioning within the target window. This allows for better prediction of the patient's daily life events, such as risks like side effects or increased fatigue. Knowing where the therapeutic effect is present—for example, that the concentration of the active substance in their body is located within the target window—the patient has the opportunity to rest while performing all activities without fear of the success of their therapeutic treatment.

[0123] Tmax, the time before the response to a specific therapeutic treatment falls below the minimum threshold of the target window, and Tmin, the time during which the response to a specific therapeutic treatment does not exceed the maximum threshold of the target window. These two pieces of information also refer to patient, subject I i For example, it enables better and more advantageous prediction of life events such as sleep, side effects, work-related travel, and extracurricular activities.

[0124] In practice, providing patients with the time interval buffer Tmax and / or the time interval buffer Tmin enables them to better understand their therapeutic treatment, take the correct dosage, and be more flexible and comfortable in managing their treatment while maintaining an optimal balance of efficacy and toxicity.

[0125] Ultimately, it can be assumed that the proposed system enables patients to manage their medication in terms of dosage and intervals between doses while cooperating with the prescriber to optimally control their therapeutic effects; this leads to individualized and variable dosing regimens over time.

[0126] Through this information, the patient can know how much time remains until their therapeutic response occurs, not only in the efficacy loss buffer region but also beyond the critical efficacy loss region, for example, when the concentration of the active substance of the therapeutic treatment in the body drops below the efficacy loss buffer threshold. It is actually advantageous to inform the patient through the efficacy loss buffer region that, for example, if the patient does not take the therapeutic treatment or perform the therapeutic treatment action within this timeframe, they remain with the patient two hours before it drops to the critical efficacy loss region.

[0127] In addition, through this information, the patient can know how much time has been spent to ensure that the therapeutic effect, for example, the concentration of the active substance of the therapeutic treatment does not exceed the toxic buffer zone or remains within the toxic buffer zone. It is actually advantageous to inform the patient, through the toxic buffer zone, that, for example, if the patient takes a therapeutic treatment or performs a therapeutic action within this timeframe, they must wait 2 hours to receive treatment or perform a therapeutic action in order to avoid entering the critical toxic zone.

[0128] This is particularly advantageous for patients who wish to coordinate the administration of therapeutic measures or the performance of therapeutic actions in the event of contingencies or routine events. For example, the patient is positioned within the optimal area of ​​the target window, and using data according to the present invention, the patient has the opportunity to perform a drug administration, e.g., taking a half-tablet, or to perform a therapeutic action at an ideal time while remaining below the critical toxicity threshold, and the patient can know the time remaining before falling into the critical efficacy loss area. This provides the patient with autonomy and comfort regarding therapeutic measures and enables them to anticipate daily life events such as work-related travel, any activities, and necessary sleep time.

[0129] In addition, medical professionals have the opportunity to adjust the dosage regimen of therapeutic treatment or make therapeutic decisions.

[0130] In another embodiment, the method according to the present invention further comprises the step of displaying at least one piece of data, preferably by an information device, e.g., a display device.

[0131] In fact, the indication of at least one piece of data is patient, object I i It is particularly advantageous because it enables the provision of clear, accurate, directly accessible, and easy-to-understand pieces of information to the recipient.

[0132] In addition, by accessing clear, accurate, and easy-to-understand information indicating their positioning within the target window, patients can optimize their use of therapeutic treatment or therapeutic actions, for example, to reduce the side effects of difficult treatments. In fact, patients may choose to take, for example, half-tablets every 12 hours for therapeutic treatment, instead of taking a full tablet every 24 hours for full therapeutic treatment.

[0133] Advantageously, the method according to the present invention further comprises the step of transmitting a therapeutic effect, preferably a visual or audible warning signal, when passed by a first device and / or an electronic monitoring device and / or a smart device (tablet, watch, smartphone, etc.), at each moment t, present or future, below a minimum threshold, e.g., of loss of efficacy, above a maximum threshold, e.g., of toxicity, below a minimum buffer threshold, e.g., of loss of efficacy, above a maximum buffer threshold, e.g., of toxicity.

[0134] In addition, according to the present invention, it is particularly advantageous that an information device, and / or a first device, and / or an electronic monitoring device, and / or a display device, and / or a smart device capable of transmitting an alarm signal, which allows for the display of at least one piece of data, is equipped with an interface, more specifically equipped with a smart personal assistance system, and more generally equipped with a smart personal assistant, also known as a so-called virtual personal assistant. This also enables performing tasks or services for the object by sending signals, such as information, alarms, reminders, etc., to the object. The interface, more specifically the smart personal assistant, can interact with the patient, transmit signals, and provide information through written communication and / or voice communication. Examples include Alexa, Google Assistant, Google Now, Cortana, BlackBerry Assistant, Bixby, Siri, Viv, etc.

[0135] In fact, according to the present invention, it is particularly advantageous to be able to provide an alarm signal to the patient at each moment t, present or future, when the therapeutic effect of the therapeutic treatment passes one of the mentioned thresholds.

[0136] Advantageously, the method according to the present invention, by means of a first device, receives a piece of data associated with taking the therapeutic treatment or performing the therapeutic treatment act, and then object I i Object I from the above-mentioned expected data model and the above-mentioned displayed data iThe method further includes the step of calculating an individualized data model, preferably for at least 2 half-lives of the therapeutic treatment, preferably for at least 2.5 half-lives of the therapeutic treatment, advantageously for at least 3 half-lives of the therapeutic treatment, advantageously for at least 4 half-lives of the therapeutic treatment, preferably for at least 5 half-lives of the therapeutic treatment, and includes the step of calculating after receiving for a duration of at least 5 half-lives of the therapeutic treatment.

[0137] In fact, the more the first device receives the aforementioned indication data regarding taking a therapeutic treatment or performing a therapeutic treatment act, the more object I i The individualized data model becomes more precise and reflects reality.

[0138] For example, the step of receiving the above indication data regarding the duration of one half-life of a therapeutic treatment is, Object I i The step of enabling the calculation of an individualized data model of and receiving the above-mentioned indication data regarding the duration of the 2-half-life of the therapeutic treatment comprises: individual I i The step of enabling the calculation of a better individualized data model of and receiving the above-mentioned indication data regarding the duration of the 3 half-lives of the therapeutic treatment is the entity I closest to reality. i It enables the calculation of individualized data models.

[0139] Advantageously, the method further includes the step of excluding a first indication data received from a set of indication data of taking a therapeutic treatment or performing a therapeutic treatment act by the first device.

[0140] Excluding the first display data received from the set of display data by the first device is object I i It appears particularly advantageous that the individualized model can reflect reality at each moment t while optimizing essential computation time and required storage space without significantly losing precision.

[0141] In fact, a predetermined number of first display data, for example, 1 display data, 2 display data, 3 display data, 4 display data, is excluded by the first device from receiving, for example, 10 display data, 9 display data, 8 display data, 7 display data, etc.

[0142] This is advantageous, individual I i To calculate an individualized model, it is possible to preserve indicator data of the most recent and most representative therapeutic intervention or therapeutic intervention behavior of the patient at moment t.

[0143] Object I according to the present invention i Other embodiments of a method for supporting taking therapeutic treatment for or performing therapeutic treatment acts are indicated in the appended claims.

[0144] The present invention also includes object I i A system intended to support taking therapeutic treatment or performing therapeutic treatment acts for, wherein the system comprises:

[0145] - First device,

[0146] - Database,

[0147] - Display device,

[0148] - Electronic monitoring device

[0149] It includes, and is configured to implement the steps of the method according to the present invention.

[0150] Actually, object I including a first device, a database, a display device, and an electronic monitoring device i It appears possible to implement the steps of the method according to the present invention in a system intended to support taking therapeutic treatment for or performing therapeutic treatment actions.

[0151] In practice, the database contains data on drugs, and such data includes a series of pharmacokinetic and / or pharmacodynamic models of at least one specific therapeutic treatment for at least one specific indication, and target windows for each specific therapeutic treatment. The database includes a communication unit. Additionally, data a), b), and c) are also stored and recorded in this database or another database.

[0152] The electronic monitoring device includes a power supply, a sensor, a processor, a communication unit, a clock, and memory. The above elements may be contained in one or more electronic devices. Object I i Whether the sensor of the electronic monitoring device operates automatically when A performs a therapeutic treatment or acts of therapeutic treatment, for example, in the case of a push button, Object I regarding the sensor i The action is recorded as an event of taking a therapeutic treatment or performing a therapeutic treatment act. The processor is configured to process the event of taking a therapeutic treatment or performing a therapeutic treatment act and to generate a signal containing indication data associated with taking a therapeutic treatment or performing a therapeutic treatment act. This indication data includes a timestamp, actual or assumed dosage, and a history of receiving treatment or performing a therapeutic act. In practice, the processor records the indication data associated with taking a therapeutic treatment or performing a therapeutic treatment act in the memory of the electronic monitoring device.

[0153] The first device of the system according to the present invention includes a power source, a processor, a communication unit, and a memory, and is configured to implement a step of calculating the method according to the present invention based on data received from a database and an electronic monitoring device.

[0154] A display device that can be integrated into a device includes a power supply, a communication unit, and a processor, and object I i It is configured to provide clear, accurate, simple, directly accessible, and easy-to-understand information.

[0155] In a preferred embodiment of the system according to the present invention, the first device, the display device, and the electronic monitoring device are integrated into a single case.

[0156] In another embodiment of the system according to the present invention, the first device and the display device are integrated into a case separated from the electronic monitoring device.

[0157] In another embodiment of the system according to the present invention, the electronic monitoring device and the display device are integrated into a case separated from the first device.

[0158] In another embodiment of the system according to the present invention, the first device and the electronic monitoring device are integrated into a case separated from the display device.

[0159] In another embodiment of the system according to the present invention, the electronic monitoring device, the display device, and the first device are integrated into a separate case.

[0160] Advantageously, the system according to the present invention is characterized in that the first device, the database, the display device, and the electronic monitoring device include a communication unit and can be connected by a communication method via wireless communication or physically connected for data exchange.

[0161] Advantageously, the electronic monitoring device of the system according to the present invention further comprises at least one power source, at least one sensor, at least one processor, at least one clock, at least one communication unit, and at least one memory. The elements may be contained in one or more electronic devices. The electronic monitoring device is configured to generate indication data associated with taking a certain therapeutic treatment or performing a therapeutic treatment, including a time stamp, a dosage, and a history of taking the therapeutic treatment or performing the therapeutic treatment.

[0162] Other embodiments of the system according to the present invention are set forth in the appended claims.

[0163] The present invention relates to a computer program product, which includes a program for a first device comprising a portion of software code for implementing the steps of a method according to the present invention when the program is executed on the first device.

[0164] In an advantageous embodiment, a computer program product according to the present invention comprises a computer-readable medium on which a portion of software code is stored, wherein the program can be directly loaded into the internal memory of a first device.

[0165] Other embodiments of the computer program product according to the present invention are set forth in the appended claims.

[0166] The present invention further includes object I i A second method for supporting taking therapeutic treatment or performing a therapeutic treatment act for, said method comprises the following steps:

[0167] - A step of obtaining data of therapeutic treatments, such as a series of pharmacological models for at least one predetermined indication and a target window for each predetermined therapeutic treatment, from a database (3) by the first device (2);

[0168] - A step of obtaining specific data of object Ii, including the following, by means of the first device (2):

[0169] a) Variable data of individual Ii selected from the group of dosage, dosage regimen, and time for taking each specified therapeutic treatment;

[0170] - By the first device (2), the series of pharmacological models and the individual I i Object I from the variable data of i Step to calculate the expected data model.

[0171] This second method for supporting taking therapeutic treatment or performing therapeutic treatment acts is characterized by further including the following steps:

[0172] - A step of receiving from an electronic monitoring device (4) display data associated with taking a predetermined therapeutic treatment or performing a therapeutic treatment act, including, in particular, a time stamp, a dosage, and a history of taking a therapeutic treatment or performing a therapeutic treatment act, by means of the first device (2);

[0173] - After receiving at least a fragment of data associated with taking the aforementioned prescribed therapeutic treatment or performing the therapeutic treatment act by the first device (2), individual I i From the above expected data model of object I i A step of calculating the individualized data model and the indicated data;

[0174] - An entity I based on indication data associated with taking the predetermined therapeutic treatment or performing the therapeutic treatment act at each moment t by the first device (2). i A step of calculating an individualized data model, wherein the individualized model comprises the value of the effect at each moment t, and entity I i A calculating step that considers the whole or part of the value of taking a predetermined prior therapeutic treatment or performing a prior therapeutic treatment act, the time stamp of taking the therapeutic treatment or performing a therapeutic treatment act, and the dosage of taking the therapeutic treatment or performing a prior therapeutic treatment act.

[0175] When the individual begins their therapeutic treatment, they perform the first therapeutic treatment or therapeutic act and record the event of receiving or performing this treatment on an electronic monitoring device. Subsequently, the patient continues their therapeutic treatment, and whenever they take a therapeutic treatment or perform a therapeutic act, the event of receiving or performing the treatment is continuously recorded on each electronic monitoring device.

[0176] The first device receives instruction data associated with taking a predetermined therapeutic treatment or performing a therapeutic treatment act, and then object I i Calculate the individualized data model of.

[0177] According to the present invention, by receiving a fragment of data associated with taking the predetermined therapeutic treatment or performing the therapeutic treatment act, by means of a first device, object I i It shows that it is possible to calculate an individualized data model.

[0178] The first device, at each moment t, present or future, object I i Calculate the individualized model of, and entity I iThe best individualized model of is, for Subject I from the above predicted data model of Subject Ii during a duration of one half-life of the minimum therapeutic treatment i The individualized data model and the indicated data are obtained after receiving the indicated data during a duration of at least 2 half-lives of the therapeutic treatment, preferably at least 2.5 half-lives of the therapeutic treatment, advantageously at least 3 half-lives of the therapeutic treatment, advantageously at least 4 half-lives of the therapeutic treatment, preferably at least 5 half-lives of the therapeutic treatment.

[0179] As the half-life of a therapeutic treatment, this refers, in the sense of the present invention, to the time it takes to lose half of the pharmacological or physiological activity of an active substance, e.g., a molecule, drug, or active ingredient.

[0180] In fact, the more the first device receives the aforementioned indication data of taking a therapeutic treatment or performing a therapeutic treatment act, the more object I i The individualized data model becomes more precise and reflects reality.

[0181] For example, receiving the above indication data during the duration of one half-life of the therapeutic treatment is Object I i It is possible to compute an individualized data model of, and receiving the above-mentioned indication data during the duration of the 2 half-life of the therapeutic treatment, Subject I i It can enable the calculation of a better individualized data model, and receiving the above-mentioned indicator data during the 3-half-life duration of the therapeutic treatment is the most realistic entity I i It can make it possible to calculate individualized data models.

[0182] Advantageously, the second method further includes the step of excluding the first indication data received from the set of indication data of taking a therapeutic treatment or performing a therapeutic treatment act by the first device.

[0183] Excluding the first display data received from the set of display data by the first device is object I i It appears particularly advantageous that the individualized model can reflect reality at each moment t while optimizing essential computation time and required storage space without significantly losing precision.

[0184] In fact, a predetermined number of first display data, for example, 1 display data, 2 display data, 3 display data, 4 display data, is excluded by the first device from receiving, for example, 10 display data, 9 display data, 8 display data, 7 display data, etc.

[0185] This is advantageous, individual I i To calculate an individualized model, it is possible to preserve indicator data of the most recent and most representative therapeutic intervention or therapeutic intervention behavior of the patient at moment t.

[0186] In addition, the second method according to the present invention comprises parameters of a pharmacological model for individual Ii selected from a physiological group (e.g., body weight, age, sex) of genetic markers by the first device, wherein individual I i It includes a step of obtaining specific data of.

[0187] The second method according to the present invention comprises, by the first device, an individual I selected from the group of measured effect of treatment, measured concentration, side effects, expected half-life, expected duration of action, and cost / effectiveness ratio. i Object I including medical datai It further includes a step of obtaining specific data of.

[0188] The second method according to the present invention, by means of the first device, object I i Object I of the expected data model i Object I of the modified data model i Object I of the individualized data model i Pharmacological model for and / or the above entity I i It further includes a step of calculating from the parameters of the medical data.

[0189] Actually, the first device according to the present invention is object I i Parameters of the pharmacological model for and / or object I i It is particularly advantageous that acquiring medical data enables the calculation of an expected data model that approaches reality. In fact, the first device according to the present invention [individual] I i The more specific data of is acquired, the more entity I i The predicted data model or the modified data model will be more accurate and complete.

[0190] Advantageously, the second method is by means of the first device, object I i Object I in the target window of the therapeutic treatment from the individualized model above i The method further includes the step of calculating positioning data and indication data of taking the therapeutic treatment or performing the therapeutic treatment act, wherein the target window includes minimum and / or maximum threshold values, for example, a predetermined efficacy loss threshold and / or a predetermined toxicity threshold.

[0191] In a preferred embodiment, the second method is by means of the first device, object I in the target window of the predetermined therapeutic treatment. iThe method further includes the step of calculating the time interval Tmin to be observed before taking the next therapeutic treatment or performing the next therapeutic treatment action from the above positioning data.

[0192] In another preferred embodiment of the second method according to the present invention, the second method further comprises the step of calculating, by the first device, a time interval Tmax to be observed for taking the next therapeutic treatment or performing the next therapeutic treatment act from the positioning data of object Ii in the target window of the predetermined therapeutic treatment.

[0193] Particularly advantageously, calculating the time interval Tmin to be observed before taking the next therapeutic treatment and / or the time interval Tmax to be observed for taking the next therapeutic treatment by the first device appears to make it possible to provide patients with accurate and simple information to understand the future of their therapeutic regimen, namely, the time interval between Tmin and Tmax at which the taking of the next therapeutic treatment and the taking of the next therapeutic treatment act must occur.

[0194] By the first device, the calculation of the time interval Tmin to be observed for taking the following therapeutic treatment is patient, individual I i a, such as therapeutic effects, for example, individual I i Information can be provided regarding the minimum time prior to which therapeutic treatment or therapeutic treatment activities should not be performed so that the concentration of the active substance does not exceed a predetermined toxicity threshold.

[0195] By the first device, the calculation of the time interval Tmax to be observed for taking the next therapeutic treatment is patient, individual I ia. Information can be provided regarding the maximum time prior to which therapeutic treatment or therapeutic treatment actions must be performed so that, for example, the concentration of an active substance in the body does not fall below a predetermined efficacy loss threshold, such as therapeutic effects.

[0196] In fact, in both cases, it is undesirable for the passage of therapeutic effect, e.g., the concentration of the active substance, to exceed the toxicity threshold or the efficacy loss threshold, and by limiting the passage of the critical threshold as much as possible, individual I i Positioning the concentration of the active substance within the target window is important for the success of the therapeutic treatment.

[0197] Unlike providing information about the past or a score regarding the history of a patient's therapeutic adherence, according to the present invention, the first device provides a time indication that can be expressed as a number of hours and / or minutes (whether a whole number or not) to be observed in the future:

[0198] - Therapeutic response, e.g., individual I i Taking the following therapeutic treatment or performing the following therapeutic action so that the concentration of the active substance does not exceed the time interval Tmin of the maximum threshold, e.g., a predetermined toxicity threshold,

[0199] - Therapeutic response, e.g., individual I i It is provided for taking the following therapeutic treatment or performing the following therapeutic treatment act so that the concentration of the active substance does not fall below a minimum threshold, e.g., a predetermined loss of efficacy, at a time interval Tmax.

[0200] Accordingly, the second method according to the present invention optimizes the therapeutic treatment effect by guiding the individual to take future therapeutic treatment or perform future therapeutic treatment actions by not providing the individual with a single indication of past effects that are too late to act on in any case.

[0201] In addition, for patients receiving treatment with a pain-relieving active substance, this allows them to know, for example, that they have 5 hours remaining until pain is relieved without the ratio of the pain-relieving active substance in their body falling below the efficacy loss threshold.

[0202] Advantageously, the second method according to the present invention, by means of the first device, in the target window of the predetermined therapeutic regimen, object I i It further includes the step of calculating at least one time interval buffer Tmin from the above positioning data before taking the above therapeutic treatment or performing the therapeutic treatment act.

[0203] Advantageously, the second method according to the present invention, by means of the first device, object I i The method further includes the step of calculating at least one time interval buffer Tmax for taking the next therapeutic treatment or performing the next therapeutic treatment action from the above positioning data, in the target window of the above-mentioned therapeutic treatment.

[0204] Existing target windows, for example, therapeutic windows, include three regions, and therapeutic effects, for example, Subject I i The concentration of the active substance for includes an optimal zone, which is the extent to which the therapeutic treatment produces the desired, curative, palliative, and preventive effects; a toxicity zone limited to the optimal zone by a predetermined toxicity threshold; and a loss of efficacy zone separated from the optimal zone by a loss of efficacy threshold.

[0205] According to the present invention, it appears particularly advantageous to provide a therapeutic window having five regions, for example, including three prior regions, and further including an efficacy loss buffer region and a toxicity buffer region.

[0206] The efficacy loss buffer region makes it possible to predict the flow of therapeutic effects, such as the concentration of an active substance for an object in the efficacy loss region, for example.

[0207] The toxicity buffer region allows for the prediction of the flow of therapeutic effects of the concentration of an active substance on an individual, for example, within the toxicity region.

[0208] According to the present invention, advantageously, the step of calculating the time interval buffer Tmin and / or the time interval buffer Tmax by the first device appears to enable providing patients with more flexibility and comfort in managing their therapeutic treatment.

[0209] In addition, the validity loss and toxicity buffer regions can be changed on the one hand, and dynamic on the other.

[0210] In practice, depending on the patient's perception, for example, patients who experience severe side effects after taking or performing a therapeutic treatment can lower the toxicity buffer zone to reduce the sensation of side effects, either by self-decision or through a medical professional.

[0211] Furthermore, it is important to instill a habit of taking or performing therapeutic treatments in the patient, and for this purpose, a dynamic buffer zone is required. The goal is to start the patient with a narrow optimal zone—namely, a significant toxicity buffer zone and a significant loss of efficacy buffer zone—to help the patient develop a habit of taking or performing regular therapeutic treatments. Once the patient establishes a habit of taking or performing therapeutic treatments, the toxicity and loss of efficacy buffer zones can be reduced and limited, while the optimal zone expands, providing greater comfort and flexibility in the management of their therapeutic treatments.

[0212] In another embodiment, the method according to the present invention, by means of a first device, in the target window of the predetermined therapeutic treatment, object I i From the above positioning data, prior to receiving the next treatment or performing the next therapeutic treatment, at least one second time interval buffer Tmin and / or object I in the target window of the above predetermined therapeutic treatment i The method further includes the step of calculating at least one second time interval buffer Tmax for taking the next therapeutic treatment or performing the next therapeutic treatment action from the above positioning data.

[0213] Furthermore, a buffer zone exists regardless of the patient and includes the characteristics of the drug. This buffer zone can be adjusted by the patient or a healthcare professional, may be modified preventively or not, and enables taking measures in accordance with advice regarding taking therapeutic treatment or performing therapeutic actions provided by a healthcare professional.

[0214] Advantageously, object I in the above target window iThe positioning data represents at least one piece of information selected from the group consisting of the following:

[0215] - Time of taking therapeutic treatment, time of performing previous therapeutic treatment actions,

[0216] - Object I i Response of a pharmacological model to a specific therapeutic treatment for

[0217] - Time, Tmax, before the response to a specific therapeutic treatment falls below the minimum threshold of the specified target window

[0218] - Time, Tmin, such that the response to a specific therapeutic treatment does not exceed the maximum threshold of a specific target window.

[0219] Advantageously, the positioning data further indicates at least one time interval buffer Tmax before the response to a given therapeutic treatment falls below the minimum buffer threshold of the target window.

[0220] Advantageously, the positioning data additionally indicates at least one time interval buffer Tmin such that the response of a given therapeutic treatment does not exceed the maximum buffer threshold of the target window.

[0221] In fact, it is positioning data representing the following:

[0222] The time of previous therapeutic treatment or the time of previous therapeutic action makes it possible to provide the patient with an indication of their history of therapeutic treatment and is all the more important for sick, elderly patients, or those suffering from memory impairment. In fact, an indication of the time of therapeutic treatment or previous therapeutic action provides an indication of subsequent therapeutic treatment or therapeutic action.

[0223] Object I iThe response to a specific therapeutic treatment makes it possible to provide the patient with information regarding positioning within the target dose range. This allows for the prediction of patient risks and daily events, such as side effects or increased fatigue. The patient has the opportunity to know where the therapeutic effect is located within the target window, such as the concentration of the active substance in the body, and can rest and perform all activities without fear of the success of the therapeutic treatment.

[0224] The time Tmax before the response to a given therapeutic treatment falls below a minimum threshold, e.g., a given efficacy loss threshold, and the time Tmin before the response to a given therapeutic treatment does not exceed a maximum threshold, e.g., a given toxicity threshold. These two pieces of information also refer to patient, individual I i For example, it enables better and more advantageous prediction of life events such as sleep, side effects, work-related travel, and extracurricular activities.

[0225] Advantageously, the positioning data further indicates at least one time interval buffer Tmax before the effect of a given therapeutic treatment drops below the efficacy loss buffer threshold.

[0226] Advantageously, the positioning data additionally indicates at least one time interval buffer Tmin such that the effect of a given therapeutic treatment does not exceed a toxicity buffer threshold.

[0227] In fact, providing patients with time interval buffers Tmax and / or Tmin can help them better understand their therapeutic treatment, reassure them about the correct dosage, and provide them with greater flexibility and comfort in managing their treatment.

[0228] This allows the patient to know how much time remains until their therapeutic response occurs, not only in the efficacy loss buffer region but also beyond the threshold efficacy loss region, for example, when the concentration of the active substance of the therapeutic treatment in the body drops below the efficacy loss buffer threshold. Through the efficacy loss buffer region, it is actually advantageous to inform the patient that, for example, if the patient does not take the therapeutic treatment or perform the therapeutic treatment action within this timeframe, they remain with the patient two hours before it drops to the threshold efficacy loss region.

[0229] In addition, this allows the patient to know how much time has been spent to ensure the therapeutic effect, for example, that the concentration of the active substance in the therapeutic treatment does not exceed the toxicity buffer zone or remains within the toxicity buffer zone, as well as stays below the critical toxicity zone. It is actually advantageous that the toxicity buffer zone allows the patient to be informed, for example, that they must wait two hours before receiving treatment to ensure that the therapeutic treatment or therapeutic action within this timeframe does not cross into the critical toxicity zone.

[0230] This is particularly advantageous for patients who wish to coordinate the administration of therapeutic treatments or the performance of therapeutic actions in the event of contingencies or routine events. For example, the patient is positioned within the optimal area of ​​the target window, and using data according to the present invention, the patient has the opportunity to administer a therapeutic treatment, such as a half-tablet, or to perform a therapeutic action at an ideal time while remaining below the critical toxicity threshold, and the patient can know the time remaining before falling into the critical efficacy loss area. This allows for providing the patient with autonomy and comfort regarding therapeutic treatments and enables the anticipation of daily life events such as work-related travel, any activities, and required sleep time.

[0231] In addition, medical professionals have the opportunity to adjust the dosage regimen of therapeutic treatment or make therapeutic decisions.

[0232] In another embodiment, the method according to the present invention further comprises a step of displaying at least one piece of data, preferably by an information device, e.g., a display device.

[0233] Actually, the display stage of at least one piece of data is patient, object I i It is particularly advantageous because it enables the provision of clear, accurate, directly accessible, and easy-to-understand information to the recipient.

[0234] In addition, by accessing clear, accurate, and easy-to-understand information indicating their position within the target window, patients can therefore optimize their therapeutic treatment or therapeutic actions, for example, to reduce the side effects of difficult treatments. In fact, patients may choose to take half a tablet every 4 hours, for example, instead of taking a full tablet every 8 hours, for example, as a complete therapeutic treatment.

[0235] Advantageously, the method according to the present invention further comprises a step of transmitting therapeutic effects, preferably visual or auditory, when an alarm signal is passed by a first device and / or an electronic monitoring device and / or a display device, at each moment t, present or future, below an efficacy loss threshold, above a toxicity threshold, below an efficacy loss buffer threshold, or above a toxicity buffer threshold.

[0236] In fact, according to the present invention, it is particularly advantageous to be able to provide an alarm signal to the patient at each moment t, present or future, when the therapeutic effect of the therapeutic treatment exceeds one of the mentioned thresholds.

[0237] Advantageously, the method according to the present invention, by means of a first device, object I i From the above-mentioned expected data model of and the above-mentioned indication data associated with taking the above-mentioned predetermined therapeutic treatment or performing the therapeutic treatment act, Entity I i It further includes a step of calculating the modified data model of.

[0238] Other embodiments of the second method according to the present invention are set forth in the appended claims.

[0239] The present invention will now be described in more detail with reference to the attached drawings.

[0240] FIG. 1 shows a system intended to support taking a therapeutic treatment or performing a therapeutic treatment act according to the present invention.

[0241] Figure 2 shows a theoretical expected pharmacokinetic model for a "robot" entity.

[0242] Figure 3 shows a modified pharmacokinetic model for an individual that takes into account the history of receiving treatment or performing therapeutic procedures.

[0243] Figure 4 shows an individualized pharmacokinetic model for an individual adapted to a "weekend" type event.

[0244] Figures 5a and 5b show individualized pharmacokinetic models for an object adapted to a "high variability" type event.

[0245] Figures 6a, 6b, and 6c show individualized pharmacokinetic models for an individual including time intervals Tmin and buffer Tmin for the next dose and time intervals Tmax and buffer Tmax before the next dose.

[0246] Figures 7a and 7b show theoretical expected pharmacodynamic models for a "robot" object.

[0247] Figures 8a and 8b show a modified expected pharmacodynamic model for an object considering the history of receiving treatment or performing treatment.

[0248] FIGS. 9a to 9e show examples of time gauges representing positioning data of an object in a target window for taking a therapeutic treatment or performing a therapeutic treatment act.

[0249] FIG. 1 illustrates a system (1) according to the present invention.

[0250] The system (1) according to the present invention includes a first device (2), a database (3), an electronic monitoring device (4), and a display device (5).

[0251] The first device (2) preferably includes a power supply, a processor, a communication unit, and a memory. The operation will be explained by FIGS. 2 through 9.

[0252] The power source is, for example, a battery or cell and is arranged to supply power to an electric circuit connecting other elements of the first device (2).

[0253] The communication unit of the first device (2) is arranged to communicate with the communication unit of the database (3), the communication unit of the electronic monitoring device (4), and the communication unit of the display device (5) of the system (1) according to the present invention.

[0254] The processor of the first device (2) is connected to a power supply, a communication unit, and a memory. The processor communicates with the communication unit of the first device (2) and is arranged to communicate with the communication units of the database (3), the electronic monitoring device (4), and the display device (5). The processor of the first device (2) is configured to transmit signals to the memory of the first device (2), and more specifically, to transmit signals to the memory of the first device (2) to record calculated data models.

[0255] The database (3) of the system (1) according to the present invention includes a communication unit arranged to communicate with a communication unit of the first device (2). Additionally, the database (3) includes a data model of a therapeutic treatment (also referred to as: therapeutic treatment data). The data model of a therapeutic treatment may be a pharmacokinetic and / or pharmacodynamic model for at least one specific indication. The pharmacokinetic and / or pharmacodynamic model may include a series of pharmacokinetic and / or pharmacodynamic models for at least one specific indication. The data model of a therapeutic treatment may, consequently, be a function of time f1(t) providing assimilation of the substance in the body after receiving the therapeutic treatment (e.g., pharmacokinetic model) or after performing the therapeutic treatment act, or may be a function of time f1(t) providing an effect on or in the body after receiving the therapeutic treatment (e.g., pharmacodynamic model) or after performing the therapeutic treatment act. The data model for therapeutic treatment includes, in addition to time, individual I, such as dosage, age, sex, weight, biomarkers, etc. i Parameters of (or object I iIt may have one or more additional parameters, such as specific data. The data model of a therapeutic treatment may include an analytical model (including the parameters of this function) or a digital model (including a series of data over time). The data model of a therapeutic treatment may include a continuous function with pharmacokinetic or pharmacodynamic progression over time. However, it is also possible to simplify the data model of a therapeutic treatment, for example, by defining a first value indicating that the treatment is effective or active during the first period after taking the therapeutic treatment or performing the therapeutic treatment act, and defining a second value indicating that the treatment is no longer effective or active during the second period after the first period.

[0256] The data model of a therapeutic treatment may also be a function f1(t, Mi) determined by a series of measurements Mi, as described in detail below. The data model of the therapeutic treatment is expressed by the function f1(t). The function f1(t) is constructed based on data of the response measured for an individual (e.g., concentration, measurement of effect, etc.) (individual I such as dosage, age, sex, weight, biomarkers, etc.). i The parameters of) or adjustments (as a series of data) may be made. The dosage may be an actual or assumed dosage.

[0257] Preferably, the database (3) includes a target window for each predetermined therapeutic treatment that is stored and recorded in the database (3) of the system (1) according to the present invention (e.g., a therapeutic window and / or an effectiveness threshold to be reached and / or a toxicity threshold not to be exceeded and / or a cost / benefit window and / or any other target window, and the target window may vary over time). Perhaps, object I i The parameters of are recorded in the database (3), and probably object I i The medical data is recorded in the database (3), and more specifically I i The variable data is recorded in the database (3). The database (3) may be arranged in the first device (2) or elsewhere, such as being stored on a server of an online network, for example.

[0258] For example, the database (3) may include one or more database(s). The various databases may all be located in the first device (2) or in other devices elsewhere, or may be distributed in the first device (2) and various other devices elsewhere. The term “elsewhere” means, for example, a server on an online network. In practice, the database (3) may include a first database containing therapeutic treatment data and / or target windows for each specific therapeutic treatment.

[0259] The database (3) is, for example, an object I i It may include a second database containing specific data of: a) an individual I selected from a group of weight, age, sex, or genetic or biological markers. iparameters of; b) individual I including assimilation and / or elimination of each specified therapeutic treatment i medical data of; and c) dosage, dosage regimen, and subject I selected from the group of theoretical times for taking each prescribed therapeutic treatment. i Variable data of.

[0260] The database (3) contains data on therapeutic treatments, such as a series of pharmacokinetic and / or pharmacodynamic models for at least one specific indication, a target window for each specific therapeutic treatment, and I of the following objects i It may include all third databases containing all specific data of: a) individual I selected from a group of weight, age, sex, or genetic or biological markers i parameters of; b) individual I including assimilation and / or removal of each prescribed therapeutic treatment i medical data of; and c) dosage, dosage regimen, and subject I selected from the group of theoretical times for taking each prescribed therapeutic treatment. i Variable data of.

[0261] In the example described below, all databases are stored in the first device (2) without limiting the invention. In variations, the database(s) may be stored elsewhere.

[0262] The first device (2) or the second database is object I i Individual I selected from a group of specific data, namely weight, age, sex, or genetic or biological markers i Obtains the parameters of. Entity I i These parameters are entered into the memory of the first device (2) by, for example, a doctor, a pharmacist, or the patient himself.

[0263] The processor of the first device (2) recovers these parameters and object I from the pharmacokinetic and / or pharmacodynamic model iCalculate the data model of.

[0264] The first device (2) is specific data of an object, such as resulting effects, for example, assimilation and / or removal of each specific therapeutic treatment, i.e., object I i Acquires medical data of Object I i These medical data are entered into the memory of the first device (2) by, for example, a doctor, pharmacist, or the patient themselves.

[0265] The processor of the first device (2) is object I i Medical data and objects I i From the data model of, entity I i Calculate a specific data model of.

[0266] The first device (2) is individual I i Obtain variable data, namely dosage and administration, and the theoretical time for taking each prescribed therapeutic treatment. Subject I i These variable data are entered into the memory of the first device (2) by, for example, a doctor, pharmacist, or the patient themselves.

[0267] The processor of the first device (2) is object I i Variable data and objects I i From a specific data model of, entity I i Calculates the projected data model of Entity I i The step of calculating the expected data model is optional.

[0268] Data models for therapeutic treatments are generally applied to all individuals or groups of individuals sharing specific parameters, whereas individual I i The expected data model of, in particular, entity I i It applies to. The data model of therapeutic treatment is subject I iWhere individualization is not possible, the present invention considers continuing the data model of the therapeutic treatment directly. Additionally, where individualization is not required, the present invention considers continuing the data model of the therapeutic treatment directly. Individual I i The predicted data model of is preferably a function f2(t) over time (predicted function f2(t)). The data model of the therapeutic treatment may be a series of functions of time f1(t, P) having at least one parameter of the undefined model P. Individual I i The expected data model of object I i It can be the same function f1(t, Pi)=f2(t) defined by the parameter Pi. Object I i The expected data model of also object I i It can be a function f(t, Mi) defined by a measurement Mi related to the body. The measurement can be the measurement of the concentration of substances in blood or other bodily fluids, X-rays, electrical measurements, etc., and the data model of the therapeutic treatment is individual I i It can be adapted to. The prediction function f2(t, Mi) can be determined by a series of measurements Mi. The prediction function f2(t, Pi, Mi) is determined by a series of measurements Mi and / or object I i It can be defined as the parameter Pi.

[0269] In any case, this method uses a data model of a therapeutic treatment. In an embodiment, the method according to the present invention uses a data model of a therapeutic treatment for the calculations described below. In a preferred embodiment, this method obtains entity I from the data model of a therapeutic treatment i Calculate the expected data model of, and then object I i It uses the expected data model of. The method below uses object I for calculation. i Explained using the expected data model of, but object I iThe data model of therapeutic treatment may also be used as a replacement for the expected data model.

[0270] The first device (2) receives data associated with taking a therapeutic treatment or performing a therapeutic treatment act from an electronic monitoring device (4). The indication data includes, in particular, a timestamp of taking a therapeutic treatment or performing a therapeutic treatment act and optionally a dosage of taking a therapeutic treatment or performing a therapeutic treatment act. The timestamp of taking a therapeutic treatment or performing a therapeutic treatment act is the instant at which taking a therapeutic treatment or performing a therapeutic treatment act occurs. For example, the actual or assumed dosage may be an intensity (e.g., for the act). The processor of the first device (2) receives from the indication data associated with taking a therapeutic treatment or performing a therapeutic treatment act and object I i From the expected data model of (or from the data model of the therapeutic treatment), entity I i Calculate the modified data model of Entity I i The modified data model of is an indicator of taking current or future therapeutic treatment or performing therapeutic treatment behavior. Preferably, individual I iThe modified data model of is a function of time f3(t) (modified function) or includes it. Preferably, the modified function f3(t) is updated with each time stamp received from the monitoring device (4) for taking a therapeutic treatment or performing a therapeutic treatment act. The timestamps for taking a therapeutic treatment or performing a therapeutic treatment act are defined as t1, t2, ..., tj. The last timestamp tj represents the timestamp for taking the last therapeutic treatment or performing a therapeutic treatment act (in relation to the current moment). The next timestamp tj+1 is the (planned) time for taking the next therapeutic treatment or performing the next therapeutic treatment act (in relation to the current moment). Preferably, the modified function f3(t) and / or entity I i The modified data model of is determined iteratively with each time stamp of taking a therapeutic treatment or performing a therapeutic treatment act received from the monitoring device (4). The iterative manner may also include a recursive manner. Preferably, each time stamp tj of taking a therapeutic treatment or performing a therapeutic treatment act received from the monitoring device (4) corresponds to another iteration j+1. Preferably, for each iteration j+1, entity I i Another modified data model of is object I of the last iteration j at the time / timestamp tj of taking the last therapeutic treatment or performing the last therapeutic treatment act. i The modified data model of (residual value of iteration j+1) and entity I i Object I of the expected data model (or data model of therapeutic treatment) i It is determined based on the modified data model. Preferably, in each iteration j+1, another modified function f3j+1 (t) is the time / time stamp tj of taking the last therapeutic treatment or performing the last therapeutic treatment action, a modified function f3 of the last iteration j j It is determined based on (tj) (residual value of iteration j+1) and the expected function of time f2(t) (or the function of time f1(t)). Preferably, for each recursion cycle j+1, another modified function f3 j+1 (t) is determined based on the time prediction function f2(t, xj+1) based on the residual xj+1 of iteration j+1 (or the time function f1(t, xj+1) based on the residual xj+1 of iteration j+1). Preferably, the time prediction function f2(t, xj+1) based on the residual xj+1 of iteration j+1 (or the time function f1(t, xj+1) based on the addition of the residual xj+1 of iteration j+1) is determined based on the sum of the residual of iteration j+1 and the time prediction function f2 (or the time function f1(t)).

[0271] Indication data associated with taking a therapeutic treatment or performing a therapeutic treatment act may also include a dosage Dj of j of taking the last therapeutic treatment or performing the last therapeutic treatment act, and the processor of the first device (2) from the time of taking the therapeutic treatment or performing the therapeutic treatment act (preferably the time tj of taking the last therapeutic treatment or performing the last therapeutic treatment act), from the dosage of taking the therapeutic treatment or performing the therapeutic treatment act (preferably the dosage Dj of taking the last therapeutic treatment or performing the last therapeutic treatment act), and object I i From the expected data model of (or from the data model of the therapeutic treatment) Entity I i Calculate the modified data model of. Preferably, for each iteration j+1, entity I iAnother modified data model of is iteration j+1, object I i It is determined based on the expected data model (or the data model of the therapeutic treatment) and the residual value of the dosage Dj. Preferably, for each recursive cycle j+1, another modified function f3 j+1 (t) is determined as a function of dose Dj (or as a function of time f1(t, Dj) and dose Dj) based on the residual value of the cycle j+1 and the expected function of time f2(t, Dj).

[0272] Between the time tj of taking the last therapeutic treatment or performing the last therapeutic action and the time tj+1 of taking the next therapeutic treatment or performing the next therapeutic action, the current or future process / progress of the therapeutic treatment over time is subject to individual I (of repetition j+1). i function f3 modified by the modified data model j+1 It can be explained by (t).

[0273] The processor of the first device (2) at each moment t, present or future, object I i From the modified data model of and indication data associated with taking a specific therapeutic treatment or performing a therapeutic treatment act, Entity I i Calculates the individualized data model of Entity I i The individualized data model of is entity I that describes the future course / progress of therapeutic treatment i It is another name for the modified data model of and is no longer distinguished below. In the disclosure below, entity I i Individualized data model and entity I i The modified data models are interchangeable.

[0274] The processor of the first device (2) preferably calculates time information for taking the next therapeutic treatment or performing the next therapeutic treatment act of the said therapeutic treatment. This information is future information and corresponds to a piece of information valid between the current time and the time calculated for taking the next therapeutic treatment or performing the next therapeutic treatment act (not a simple alarm). This information may include a planned time that may elapse until taking the next therapeutic treatment or performing the next therapeutic treatment act of the said therapeutic treatment. This information includes a planned maximum time for taking the next therapeutic treatment or performing the next therapeutic treatment act of the said therapeutic treatment, a planned maximum buffer time for taking the next therapeutic treatment or performing the next therapeutic treatment act of the said therapeutic treatment, a planned minimum time for taking the next therapeutic treatment or performing the next therapeutic treatment act of the said therapeutic treatment, a planned minimum buffer time for taking the next therapeutic treatment or performing the next therapeutic treatment act of the said therapeutic treatment, or a combination of these times. Each time can be expressed as an absolute time (hour, date, etc.) or a time interval (e.g., for maintenance for the next dose within 6 hours).

[0275] The minimum time is the minimum time that must be reached before taking or performing the next therapeutic treatment. The minimum time is less than or equal to the minimum buffer time, maximum buffer time, or maximum time. Object I i If the following therapeutic treatment is received or performed again before the minimum time required to elapse, the therapeutic treatment is for overdose and / or individual I i enters an undesirable area or object I i It can have undesirable effects, such as entering the same-sex zone of therapeutic treatment.

[0276] The minimum buffer time is the minimum time that must be reached before taking or performing the next therapeutic treatment to achieve an optimized effect. The minimum buffer time is less than or equal to the maximum buffer time or maximum time and greater than or equal to the minimum time. Object I i If the following therapeutic treatment is received or performed again, between the minimum time and the minimum buffer time, the therapeutic treatment has no undesirable effects, but is not optimal or individual I i It is not a case where it falls within the buffer toxicity range of therapeutic treatment.

[0277] The maximum time is at the latest before the time when the next therapeutic treatment must be received or performed. The maximum time is greater than or equal to the minimum buffer time, maximum buffer time, or minimum time. Subject I i If the following therapeutic treatment is received or performed again after the maximum time has elapsed, the therapeutic treatment loses its effectiveness and / or individual I i It enters the loss of validity area.

[0278] The maximum buffer time is the time after which the next therapeutic treatment can already be taken or performed so that the next therapeutic treatment has a discontinuous effect without toxicity or side effects. The maximum buffer time is less than or equal to the maximum time and greater than or equal to the minimum time or minimum buffer time. Subject I i If the following therapeutic treatment is received or performed again between the minimum buffer time and the maximum buffer time, the therapeutic treatment is optimal and / or individual I i A is in the optimal region (therapeutic window) with no loss of efficacy, and there are no side effects while maintaining the continuity of therapeutic treatment. Individual I i If the following therapeutic treatment is received or performed again between the maximum buffer time and the maximum time, the therapeutic treatment begins to lose its effect (acceptable) and Subject I i It enters the loss of validity buffer area.

[0279] Time information is preferably calculated using a target window as described below. However, it is also possible to calculate time information using other methods.

[0280] The calculated time information is preferably displayed on a display device (5) as shown in, for example, FIGS. 9a to 9d.

[0281] Preferably, the processor of the first device (2) receives the therapeutic treatment target window and the object I i Object I in the target window of the therapeutic treatment from the above modified model i Calculate the positioning data of.

[0282] The target window preferably includes a first threshold and a second threshold having an optimal region between the first threshold and the second threshold. The first threshold is a validity loss threshold and is generally a minimum threshold. The validity loss threshold limits the validity loss region. The second threshold is a toxicity threshold and is generally a maximum threshold. The toxicity threshold limits the toxicity region. Preferably, the target window preferably includes a first buffer threshold and a second buffer threshold. The first buffer threshold is a validity loss buffer threshold and is generally a minimum buffer threshold. The validity loss buffer threshold limits the validity loss buffer region and the optimal region. The second buffer threshold is a toxicity buffer threshold and is generally a maximum buffer threshold. The toxicity buffer threshold limits the toxicity buffer region and the optimal region. The target window and / or its thresholds, and the data model of the therapeutic treatment, the expected data model of the object and / or object I i The modified data model is represented by the same physical (or variable) parameter (e.g., concentration). Generally, this parameter is not a parameter (or variable) of time.

[0283] However, in some cases, this can be direct time.

[0284] The processor of the first device (2) is preferably object I i Calculate the current value (current value) of the above modified model and, based on the current value, object I in the above target window i Calculate the positioning of the positioning data.

[0285] Preferably, object I in the target window i The positioning of the positioning data is Object I in the time target window. i It is converted into time positioning data. Object I in the time target window i The time positioning data preferably includes one or more of a minimum time, a minimum buffer time, a maximum buffer time, and a maximum time. The minimum time is preferably object I i It is calculated based on the above-mentioned modified model and the second threshold, and preferably, receiving the following therapeutic treatment again or performing the following therapeutic treatment act is Individual I i It is calculated based on the time that makes the modified model correspond to the second threshold. The minimum buffer time is preferably calculated based on the modified model and the second buffer threshold of individual Ii, and preferably, receiving the next therapeutic treatment again or performing the next therapeutic treatment again is individual I i It is based on the time that makes the modified model correspond to the second buffer threshold. The maximum time is preferably for entity I i Based on the above modified model and the first threshold value, preferably, individual I i The modified model of is calculated based on the time at which it corresponds to or crosses the first threshold. The maximum buffer time is preferably for entity I i Based on the above modified model and the first threshold value, preferably, individual I i The modified model is calculated based on the time when it corresponds to or crosses the first buffer threshold.

[0286] Object I in the time target window i It is preferable that the time positioning data be displayed on a display device (5).

[0287] However, object I in the target window i The positioning data of object I in the time target window i It is also possible not to convert it into time positioning data. For example, Object I i This is because the modified model of already corresponds to the time scale (magnitude). In another example, entity I i Object I in the target window represented by the physical scale of the modified model i Displays the positioning of.

[0288] The electronic monitoring device (4) is object I i It is arranged to detect the time of taking therapeutic treatment or performing therapeutic treatment actions or the time of the action. Preferably, the electronic monitoring device (4) includes a communication unit arranged to communicate with the communication unit of the first device (2). Preferably, the electronic monitoring device (4) is object I i It includes sensors arranged to automatically detect taking or performing therapeutic treatment. In one embodiment, the sensor or electronic monitoring device (4) is object I i It is arranged to automatically detect the dosage of taking therapeutic treatment or performing therapeutic treatment acts. In the case of drugs, the electronic monitoring device (4) may be a device that detects the release of drugs from the packaging or detects the performance of therapeutic treatment or performing therapeutic treatment acts as a trigger for a phototherapy device. However, the electronic monitoring device (4) is individual I i The time of taking therapeutic treatment or performing therapeutic treatment actions can be detected non-automatically. For example, the electronic monitoring device (4) is object I iIt can receive input from a user (e.g., an object) indicating the moment or time of taking therapeutic treatment or performing therapeutic treatment actions. The electronic monitoring device (4) may also be an app for a smartphone, smart watch, smart glasses, smartwatch, or touchscreen tablet.

[0289] Preferably, the electronic monitoring device (4) monitors object I in real time on the first device (2). iCommunicate the time of taking a therapeutic treatment or performing a therapeutic treatment act (sometimes referred to by the abbreviation: the time of taking a therapeutic treatment or performing a therapeutic treatment act). In simpler cases, the device (4) may simply send a signal, and the device (2) may include the time of taking a therapeutic treatment or performing a therapeutic treatment act based on the time of receiving the signal. In this case, the data associated with taking a therapeutic treatment or performing a therapeutic treatment act simply corresponds to this signal. However, preferably, the device (4) transmits a signal containing indication data of taking a therapeutic treatment or performing a therapeutic treatment act to the device (2). In the sense of the invention, "real-time" means that time data (time stamp) of taking the last therapeutic treatment or performing the last therapeutic treatment act is transmitted to the first device (2), which allows for the prediction of the time or moment when the next therapeutic treatment or the next therapeutic treatment act must necessarily occur. Real-time means that time data (time stamp) of the last therapeutic treatment or therapeutic treatment action is transmitted to the first device (2) before the next therapeutic treatment or therapeutic treatment action. The treatment interval is the average or planned interval (e.g., medication regimen) of two consecutive therapeutic treatments or therapeutic treatment actions.Preferably, real-time means transmitting time data (time stamp) of taking the last therapeutic treatment or performing the last therapeutic treatment act to the first device (2) as a maximum corresponding to 50% of the treatment interval, preferably as a maximum within a time corresponding to 30% of the treatment interval, preferably as a maximum within a time corresponding to 20% of the treatment interval, preferably as a maximum within a time corresponding to 10% of the treatment interval, and preferably as a maximum within a time corresponding to 5% of the treatment interval of the time stamp of taking the last therapeutic treatment or performing the last therapeutic treatment act.

[0290] Preferably, the electronic monitoring device (4) includes a power supply, a sensor, a processor, a clock, and a memory.

[0291] Object I i Whether the sensor of the electronic monitoring device operates automatically when A performs a therapeutic treatment or acts of therapeutic treatment, for example, in the case of a push button, Object I regarding the sensor i The action is recorded as an event of taking a therapeutic treatment or performing a therapeutic treatment act. A processor is configured to process the event of taking a therapeutic treatment or performing a therapeutic treatment act and to generate a signal containing indicator data associated with taking a therapeutic treatment or performing a therapeutic treatment act. This indicator data includes a timestamp, dosage, and history of receiving treatment or performing a therapeutic act. In practice, the processor of the electronic monitoring device (4) records indicator data associated with taking a therapeutic treatment or performing a therapeutic treatment act in the memory of the electronic monitoring device (4) for a duration ranging from up to three years.

[0292] The display device (5) includes a communication unit arranged to communicate with the communication unit of the first device (2). Additionally, the display device (5) includes a power supply and a processor and object I i It is designed to provide clear, simple, accurate, directly accessible, and easy-to-understand information to.

[0293] Instead of a display device (5), an output device may be used to send only the data calculated in the first device (2) to another device, or to send an audio signal along with the data calculated in the first device (2) to an audio device. The audio device may be an audio output or a speaker. Preferably, the system (1) includes an information device that informs the user of the data calculated in the first device (2). The information device may be a display device (5), an output device, an audio device, or another information device.

[0294] In an embodiment of the system (1) according to the present invention, the first device (2), the electronic monitoring device (4), and the display device (5) are integrated into a single case. This allows an entity to have the system (1) according to the present invention integrated into a single case.

[0295] In another embodiment of the system (1) according to the present invention, the first device (2) and the display device (5) are integrated into a case separated from the electronic monitoring device (4).

[0296] In another embodiment of the system (1) according to the present invention, the first device (2) is integrated into the first case, and the electronic monitoring device (4) and the display device (5) are integrated into the second case separated from the first case.

[0297] In another embodiment of the system (1) according to the present invention, the first device (2) is integrated into the first case, the electronic monitoring device (4) is integrated into the second case, and the display device (5) is integrated into the third case separated from each other.

[0298] In another embodiment of the system (1) according to the present invention, the first device (2) and the electronic monitoring device (4) are integrated into a first case separated from the display device (5).

[0299] In another embodiment of the system (1) according to the present invention, the electronic monitoring device (4) is integrated into the first case, and the first device (2) and the display device (5) are integrated into the second case separated from the first case.

[0300] In addition, the first device (2), database (3), electronic monitoring device (4), and display device (5) of the system (1) according to the present invention may be connected by a communication method via wireless communication or physically connected for data exchange.

[0301] Figure 2 illustrates a theoretical expected pharmacokinetic model for a "robot" entity.

[0302] The predicted pharmacokinetic model is for individual I selected from the group of doses, dosing regimens, and theoretical times for taking each specified therapeutic treatment. i It may include variable data, and individuals I selected from physiological groups (e.g., weight, age, sex), genetic markers, and biological markers. i It may also include parameters of the pharmacological model for. The predicted pharmacokinetic model may further include medical data of Ii selected from the group of measured effect of treatment, measured concentration, side effects, predicted half-life, predicted duration of action, and cost / effectiveness ratio.

[0303] In fact, the first device (2) contains variable data of the object, parameters of the model for the object, and medical data of the object. These data / parameters are recorded in the memory of the first device (2).

[0304] Based on these data / parameters and a series of pharmacological models, in the present pharmacokinetic case, the first device (2) calculates an exemplary predicted pharmacokinetic model consisting of one or more equations representing the concentration of the active substance for an individual of a given therapeutic treatment for a given indication over time.

[0305] This predicted pharmacokinetic model is theoretical as a representative of a perfect entity, a "robot" entity that systematically receives or performs treatment simultaneously every day.

[0306] The concentration of the active substance for an individual increases and decreases in tandem with dosage within a target window, for example, a therapeutic window.

[0307] Figure 3 shows an entity I considering the history of receiving treatment or performing treatment acts. i Illuminates the modified pharmacokinetic model of.

[0308] The first device (2) receives indication data from an electronic monitoring device (4) associated with taking a specific therapeutic treatment or performing a therapeutic treatment act. The indication data includes, in particular, a time stamp and optionally, the administration of taking a therapeutic treatment or performing a therapeutic treatment act.

[0309] The processor of the electronic monitoring device (4) records indication data associated with taking therapeutic treatment or performing therapeutic treatment actions in the memory of the electronic monitoring device (4).

[0310] When operating, the processor of the first device (2) transmits a request to the communication unit of the first device (2). The request is transmitted by the communication unit of the first device (2) to the communication unit of the electronic monitoring device (4). The request received by the communication unit of the electronic monitoring device (4) is analyzed by the processor of the electronic monitoring device (4) which extracts display data from the memory of the electronic monitoring device, and more specifically, the extracted display data includes a time stamp, dosage, and a history of taking therapeutic treatment or performing therapeutic treatment actions. The processor of the electronic monitoring device (4) transmits the extracted display data to the communication unit of the electronic monitoring device (4). The display data is transmitted from the communication unit of the electronic monitoring device (4) to the communication unit of the first device (2). The processor of the first device (2) records the display data received by the communication unit of the first device (2) in the memory of the first device (2).

[0311] The processor of the first device (2) has indication data and object I associated with taking a predetermined therapeutic treatment or performing a therapeutic treatment act. i From the expected data model of (Fig. 2), entity I i Calculate the modified data model of.

[0312] Object I obtained by the method according to the present invention i The modified data model of is an object I modified over time i Indicates the concentration of the active substance for, and the target window, e.g., object I i It includes a therapeutic window for a specific therapeutic treatment. The modified data model is particularly advantageous in that it considers indication data associated with taking a therapeutic treatment or performing a therapeutic treatment act, and can provide a data model that takes into account differences from existing pharmacokinetic models and differences regarding prescribed treatments.

[0313] Actually, object I according to the present inventioni The modified pharmacokinetic model makes it possible to explain the following: when a peak of response is observed in the model, for example, a peak in the concentration of the active substance of a therapeutic treatment, if it coincides with the event of taking the therapeutic treatment or performing the therapeutic act, it will not be attributed to rapid assimilation but will be explained as a result of receiving the treatment or performing the therapeutic act. When a trough of the therapeutic response in the model, for example, a trough in concentration, coincides with the absence of the event of taking the therapeutic treatment or performing the therapeutic act for a certain period, it will be explained by the forgetting of taking the therapeutic treatment or performing the therapeutic act, rather than by rapid elimination.

[0314] Consequently, because the subject's modified data model considers indication data associated with taking therapeutic treatment, it can explain differences and avoid attributing changes in effect to incorrect causes.

[0315] Fig. 4 illustrates an individualized pharmacokinetic model for an object adapted to a "weekend" type event.

[0316] Object I obtained by the method according to the present invention i The individualized pharmacokinetic model of individual I over time i Indicates the concentration of the active substance for and the target window, e.g., object I i It includes a therapeutic window for a prescribed therapeutic treatment. The individualized pharmacokinetic model considers indication data associated with taking a therapeutic treatment or performing a therapeutic treatment action.

[0317] The illustrated individualized pharmacokinetic model further includes a first minimum threshold corresponding to an efficacy loss threshold, more specifically a minimum threshold efficacy loss threshold, and a first maximum threshold corresponding to a toxicity threshold, more specifically a maximum threshold toxicity threshold.

[0318] The illustrated individualized pharmacokinetic model further includes a second minimum threshold corresponding to the efficacy loss buffer threshold and a second maximum threshold corresponding to the toxicity buffer threshold.

[0319] In addition, the individualized pharmacokinetic model makes it possible to identify whether the concentration of the active substance for an object is close to a first minimum threshold, a first maximum threshold, a second minimum threshold, and a second maximum threshold at each moment t, present or future, by placing the concentration of the active substance for the object in a target window, for example, in a therapeutic window that allows the object.

[0320] The target window may change over time, and especially when an event is detected, it is necessary to educate the patient or medical staff about the cause of such behavior and about excellent therapeutic compliance.

[0321] In fact, it is observed that the concentration of the active substance passes below the second minimum threshold corresponding to the efficacy loss buffer threshold. This is explained in this case by the following fact: these doses were administered on weekends, and the patient who agreed to the sleep-like event received the treatment at 11 a.m. instead of at 8 a.m. as is done on weekdays.

[0322] With a dynamic and adjustable target window, for the purpose of maintaining the concentration of the active substance in the patient's body between the buffer thresholds of the target window to anticipate these "weekend" type events, patients or medical staff may adjust the buffer thresholds to limit and educate the patient for better treatment adherence.

[0323] Figures 5a and 5b illustrate individualized pharmacokinetic models for an individual adapted to "high variability" type events.

[0324] The individualized pharmacokinetic model of the individual represents the concentration of the active substance of the individual over time and includes its own target window, which includes threshold values ​​such as those mentioned in Fig. 4.

[0325] When a patient or medical staff detects high variability in the concentration of the active substance for an object, this leads to multiple flows exceeding the toxicity buffer threshold, or even flows exceeding the critical toxicity threshold and falling below the efficacy loss buffer threshold. Considering the stage of acquiring indication data of receiving treatment or performing treatment by the electronic monitoring device (4), high variability is described as a failure of therapeutic compliance, more specifically receiving irregular treatment or performing irregular treatment.

[0326] When high variability is detected due to therapeutic adherence, the goal is for the patient or medical staff to create a target window with a narrower buffer threshold to limit the patient from receiving treatment or performing therapeutic actions with better adherence (Fig. 5a).

[0327] When patients or medical staff observe better regularity in therapeutic adherence in response to high variability, this indicates that the patient has been properly managed to be educated in good therapeutic adherence behavior. In this case, re-adjusting the target window is possible by increasing the space between the buffer thresholds again, with the aim of providing more flexibility and comfort to the educated patient, now recognizing the importance of good therapeutic adherence (Fig. 5b).

[0328] Figures 6a, 6b, and 6c illustrate an individualized pharmacokinetic model for an individual including a time interval Tmin and buffer Tmin for the next administration and a time interval Tmax and buffer Tmax before the next administration.

[0329] The processor of the first device (2) preferably, at each moment t, present or future, object I i From the individualized data model of and indication data of taking therapeutic treatment or performing therapeutic treatment acts, Object I in the target window i positioning data of, entity I i Calculate a predetermined therapeutic treatment. The target window further includes a predetermined maximum efficacy loss threshold and a predetermined toxicity threshold.

[0330] Actually, object I i Starting with the individualized data model and presentation data of, Object I i Individualize positioning data and consider differences in therapeutic adherence.

[0331] In fact, entity I considering indication data of taking therapeutic treatment or performing therapeutic treatment actions i Based on a known concentration curve based on an individualized data model, it is possible to determine what the profile of the concentration curve is over time after receiving treatment or performing a treatment act at each moment t, now or in the future.

[0332] Tmin (Fig. 6a) is calculated as the time between the current moment and the moment when the concentration peak is reached at the limit of the toxic region. Additionally, if the concentration peak remains below the toxic region at the moment the therapeutic treatment is taken or performed, Tmin becomes 0. Just as the Tmin calculation is determined based on the time from now until the next therapeutic treatment or the next therapeutic act, it is also possible to calculate Tmin for different doses, such as receiving half the therapeutic treatment.

[0333] Buffer Tmin (Fig. 6b) is calculated as the time between the current moment and the moment when taking or performing a therapeutic treatment leads to a concentration peak at the limit of the toxic buffer region. Additionally, if the concentration peak remains below the toxic buffer region regardless of the moment of taking or performing the therapeutic treatment, Buffer Tmin is equal to 0.

[0334] This is because accessing both the time interval Tmin and the time interval buffer Tmin is particularly advantageous for patients and / or medical professionals, as it enables the anticipation of random events. For example, a patient knows that they must plan a trip of several hours to receive treatment or perform therapeutic actions, knowing not only that the toxicity buffer threshold will be exceeded but also that the critical toxicity threshold will not be exceeded.

[0335] Tmax (Fig. 6c) is calculated as the time between the current moment and the moment when the concentration falls below the limit of the efficacy loss zone if therapeutic treatment is not performed or if therapeutic treatment is not performed at this time interval Tmax.

[0336] Buffer Tmax (Fig. 6c) is calculated as the time between the current moment and the moment when the concentration falls below the limit of the effective loss buffer region if therapeutic treatment is not performed or if therapeutic treatment is not performed at this time interval buffer Tmax.

[0337] This is because it is particularly advantageous for patients and / or medical professionals to have access to both the time interval Tmax and the time interval buffer Tmax, as this makes it possible to anticipate events, for example, when a patient must take or perform a therapeutic treatment within 4 hours (buffer Tmax), but is unable to take or perform such therapeutic treatment within 4 hours, for example, there is an additional 2 hours before entering the threshold of loss of efficacy.

[0338] Furthermore, the buffer Tmin / Tmax can be adjusted by the patient or a healthcare professional based on sensations, such as strongly felt side effects. Additionally, the buffer range may be adjusted or modified to better adhere to defined habits, particularly those discernible through dosing history. In practice, the buffer Tmin / Tmax can be dynamically recalculated based on dosing history to better respond to actual behaviors (e.g., adaptations to specific behaviors that exist only on weekends, such as sleeping).

[0339] Furthermore, it is important to instill a habit of taking or performing therapeutic treatments in the patient, and for this purpose, a dynamic buffer zone is required. The goal is to start the patient with a narrow optimal zone—namely, a significant toxicity buffer zone and a significant loss of efficacy buffer zone—to help the patient develop a habit of taking or performing regular therapeutic treatments. Once the patient establishes a habit of taking or performing therapeutic treatments, the toxicity and loss of efficacy buffer zones can be reduced and limited, while the optimal zone expands, providing greater comfort and flexibility in the management of their therapeutic treatments.

[0340] This is advantageous in that it enables patients to recognize the importance of regularity in their therapeutic treatment, that is, to achieve optimal therapeutic compliance in order to remain in the optimal region of therapeutic effect within the target window. This is, at each moment t, patient, individual I i and this is possible by its positioning data.

[0341] It is important to enable patients to link their therapeutic regimens, that is, data on their therapeutic treatments, the effectiveness of the treatment, and therapeutic adherence. Subject I i The positioning data of, on the one hand, patient, entity I i a coordinates their therapeutic regimen and medical staff patient, individual I i To individualize treatment, to avoid overdose of therapeutic measures that may vary, allow for good therapeutic adherence.

[0342] The efficacy loss threshold and the toxicity threshold of the target window can be adjusted depending on whether the subject's therapeutic compliance is good or poor.

[0343] Also, object I in the above target window i The positioning data represents at least one piece of information selected from the group consisting of the following:

[0344] - Time of taking therapeutic treatment, time of performing previous therapeutic treatment actions,

[0345] - Object I i Response of a pharmacological model to a specific therapeutic treatment for

[0346] - Time, Tmax, before the response to a specific therapeutic treatment falls below the minimum threshold of the specified target window.

[0347] - Time, Tmin, such that the response to a specific therapeutic treatment does not exceed the maximum threshold of a specific target window.

[0348] Figures 7a and 7b illustrate a theoretically expected pharmacodynamic model for a "robot" object.

[0349] The predicted pharmacodynamic model is for individual I selected from the group of dosages, dosing regimens, and theoretical times for taking each specified therapeutic treatment. i It may include variable data, and additionally, individual I selected from the group of weight, age, sex, genetic markers, and biological markers. i It may include parameters of the pharmacological model for. The predicted pharmacodynamic model is an individual I selected from the group of measured effect of treatment, measured concentration, side effects, predicted half-life, and predicted duration of action. i It may include more medical data.

[0350] In fact, the first device (2) acquires variable data of the object, parameters of the model for the object, and medical data of the object. These data / parameters are recorded in the memory of the first device (2).

[0351] Based on these data / parameters and a series of pharmacological models, in the present pharmacodynamic case, the first device (2) calculates an exemplary predicted pharmacodynamic model consisting of one or more equations representing the effect of a given therapeutic treatment over time for a given indication. The effect of the treatment may change over time depending on the method of performing the treatment.

[0352] The illustrated predicted pharmacodynamic model (Fig. 7a) further includes a first minimum threshold corresponding to the validity loss threshold, more specifically, a minimum threshold validity loss threshold and a second minimum threshold corresponding to the validity loss buffer threshold.

[0353] The example predicted pharmacodynamic model (Fig. 7b) further includes a first maximum threshold corresponding to a toxicity threshold, more specifically a second maximum threshold corresponding to a maximum threshold toxicity threshold and a toxicity buffer threshold.

[0354] The frequency of therapeutic actions aims to maintain the effectiveness of the therapeutic treatment within the effectiveness window between, for example, insufficient exposure to actions that make the treatment ineffective (effectiveness loss threshold) and excessive exposure to actions that potentially make the treatment dangerous (toxicity threshold).

[0355] It is important for the patient to be able to see the effects of therapeutic treatment. In fact, for each of the actions taken or performed as a therapeutic treatment, there are related effects that can be directly identified by the patient, such as the sensation of pain, or related effects that cannot be directly identified, such as the concentration of the active substance of a therapeutic agent.

[0356] The effects associated with taking a therapeutic treatment or performing a therapeutic treatment, respectively, can be measured and / or identified by measurable or corrected therapeutic effects, such as concentrations (plasma, saliva, urine, tissue, blood, capillaries, etc.), biomarkers, and, for example, corrections to pain thresholds.

[0357] This predicted pharmacodynamic model is theoretical and represents a perfect entity, a "robot" entity that systematically performs treatment or therapeutic actions at the same time every day. The effect of treatment on the entity increases or decreases in tandem with the administration of therapeutic measures within a target window, for example, a therapeutic window.

[0358] Figures 8a and 8b illustrate a modified expected pharmacodynamic model for an entity considering the history of receiving treatment or performing treatment.

[0359] The first device (2) receives indication data from an electronic monitoring device (4) associated with taking a specific therapeutic treatment or performing a therapeutic treatment act. The indication data includes, in particular, a time stamp, a dosage, and a history of taking the therapeutic treatment or performing the therapeutic treatment act.

[0360] The processor of the electronic monitoring device (4) records indication data associated with taking therapeutic treatment or performing therapeutic treatment actions in the memory of the electronic monitoring device (4).

[0361] When operating, the processor of the first device (2) transmits a request to the communication unit of the first device (2). The request is transmitted by the communication unit of the first device (2) to the communication unit of the electronic monitoring device (4). The request received by the communication unit of the electronic monitoring device (4) is analyzed by the processor of the electronic monitoring device (4) which extracts display data from the memory of the electronic monitoring device, and more specifically, the extracted display data includes a time stamp, dosage, and a history of taking therapeutic treatment or performing therapeutic treatment actions. The processor of the electronic monitoring device (4) transmits the extracted display data to the communication unit of the electronic monitoring device (4). The display data is transmitted from the communication unit of the electronic monitoring device (4) to the communication unit of the first device (2). The processor of the first device (2) records the display data received by the communication unit of the first device (2) in the memory of the first device (2).

[0362] The processor of the first device (2) derives from indication data associated with taking a predetermined therapeutic treatment or performing a therapeutic treatment act and object I i Object I of the expected pharmacodynamic data model (Figs. 7a and 7b) i Calculate the modified pharmacodynamic data model of (Figs. 8a and 8b).

[0363] Object I obtained by the method according to the present inventioni The modified pharmacodynamic model of represents the effect of the modified therapeutic treatment over time and includes a target window.

[0364] A modified pharmacodynamic model (Fig. 8a) that takes into account the exemplified history of receiving treatment or performing a treatment act further includes a first minimum threshold corresponding to a second minimum threshold corresponding to a validity loss threshold, more specifically, a minimum threshold validity loss threshold and a validity loss buffer threshold.

[0365] A modified pharmacodynamic model (Fig. 8b) that takes into account the exemplified history of receiving treatment or performing treatment further includes a first maximum threshold corresponding to a toxicity threshold, more specifically a maximum threshold toxicity threshold and a second maximum threshold corresponding to a toxicity buffer threshold.

[0366] The frequency of therapeutic actions aims to maintain the effectiveness of the therapeutic treatment within the efficacy window between, for example, insufficient exposure to actions that render the treatment ineffective (efficacy loss threshold) and excessive exposure to actions that potentially render the treatment dangerous (toxicity threshold).

[0367] The modified pharmacodynamic model is particularly advantageous because it considers indication data associated with taking or performing therapeutic treatments, and can provide a pharmacodynamic model that takes into account the differences from existing models that consider variations in prescribed treatments.

[0368] Actually, object I according to the present invention iThe modified pharmacodynamic model makes it possible to explain the following: when a peak of response is observed in the model, for example, a peak of the effect of a therapeutic treatment, if it coincides with the event of taking the therapeutic treatment or performing the therapeutic act, it will be explained as a result of receiving or performing the treatment. When a trough of the therapeutic response in the model, for example, a trough of the effect of a therapeutic treatment, if it coincides with the absence of the event of taking the therapeutic treatment or performing the therapeutic act for a certain period, it will be explained as the forgetting of taking the therapeutic treatment or performing the therapeutic act.

[0369] Consequently, because the subject's modified data model considers indication data associated with taking therapeutic treatment, it can explain differences and avoid attributing changes in effect to incorrect causes.

[0370] FIGS. 9a, 9b, 9c, 9d, and 9e illustrate examples of implementations of time gauges representing positioning data of an object in a target window for receiving treatment or performing a treatment, each part representing one hour.

[0371] Figure 9a shows a time gauge indicating an object that receives or performs the act of treatment again.

[0372] When the time gauge is filled to 100%, all parts are filled, and the object is located in the upper buffer area between the maximum threshold and the maximum buffer threshold, and passes beyond the maximum threshold corresponding to the critical toxicity threshold, a penalty is applied, and therapeutic treatment or treatment actions must not be performed again.

[0373] Fig. 9b shows a time gauge indicating an object 2 hours after receiving the last treatment or performing the last treatment act.

[0374] The gauge is filled to 77%, the two sections between the maximum threshold and the maximum buffer threshold are empty, and the entity is located in the optimal area below the maximum buffer threshold corresponding to the toxicity buffer threshold. If the entity passes beyond the maximum threshold corresponding to the critical toxicity threshold, a penalty is applied, and the entity must not receive or perform the treatment act again.

[0375] However, the individual may, for example, take 1 / 4 of the tablet again without entering the toxic area to anticipate a routine event, or to receive treatment or perform a treatment act.

[0376] Fig. 9c shows a time gauge indicating the object 4 hours after receiving the last treatment or performing the last treatment act.

[0377] The gauge is filled to 55%, the two parts between the maximum threshold and the maximum buffer threshold are empty, the two parts of the optimal region are empty, and the subject is located in the optimal region below the threshold for full administration. The subject can receive or perform the treatment again without the risk of exceeding the maximum threshold corresponding to the critical toxicity threshold.

[0378] Fig. 9d shows a time gauge indicating the object 6 hours after receiving the last treatment or performing the last treatment act.

[0379] The gauge is filled to 33%, two parts between the maximum threshold and the maximum buffer threshold are empty, four parts of the optimal region are empty, and the object is located in the lower buffer region between the minimum buffer region and the minimum threshold. When three parts of the efficacy loss buffer region between the minimum buffer threshold and the minimum threshold are filled, the patient knows that the efficacy of the therapeutic treatment remains for 3 hours. The object must receive or perform the therapeutic act again within the next 3 hours under the penalty of falling below the minimum threshold corresponding to the efficacy loss threshold.

[0380] Fig. 9e shows a time gauge representing the object 9 hours after receiving the last treatment or performing the last treatment act.

[0381] The gauge is filled to 0%, the two parts between the maximum threshold and the maximum buffer threshold are empty, the four parts of the optimal region and the three parts between the minimum buffer threshold and the minimum threshold are empty. The therapeutic treatment no longer has a therapeutic effect on the subject. They must absolutely receive the treatment again or perform the treatment again.

[0382] It is well understood that the present invention is not limited in any way to the embodiments described below, and that many modifications may be applied thereto without departing from the scope of the appended claims.

Claims

Claim 1 Object I including the following steps i A method for supporting taking or acting a therapeutic treatment for: - obtaining, by means of the first device (2) from a database (3), a data model of the therapeutic treatment, a series of pharmacometrics models for at least one predetermined indication, or a target window for the therapeutic treatment; - by means of an electronic monitoring device (4), individual I i Object I, including its time stamping i A step of recording indicative data associated with taking the above-mentioned therapeutic treatment or performing the therapeutic treatment act; - by the first device (2), individual I i a. receiving the indicator data associated with taking the above therapeutic treatment or performing the therapeutic treatment act from an electronic monitoring device (4); - by the first device (2), from the data model of the above therapeutic treatment and from the indicator data associated with taking the above therapeutic treatment or performing the therapeutic treatment act, the entity I i A step of calculating a modified data model of; - by the first device (2), object I i From the above modified model of and from the above indication data of taking the above therapeutic treatment or performing the above therapeutic treatment act, object I in the above target window of the above predetermined therapeutic treatment i A step of calculating positioning data. Claim 2 In claim 1, by the first device (2), individual I i It further includes a step of obtaining specific data of, and the object I i Specific data of: - Individual I selected from a group consisting of dosing, posology, and the theoretical time for taking each specified therapeutic treatment i Variable data of - individuals selected from a physiological population including genetic markers, biological markers, body weight, age, and sex I i Subject I selected from the group consisting of the parameters of the above data model of the therapeutic treatment for, and / or - the measured effect of the treatment, measured concentration, side effects, expected half-life, expected duration of action, and cost / effectiveness ratio i Includes medical data of, and by the first device (2), object I i The projected data model of is derived from the above data model of the therapeutic treatment and entity I i It is obtained from the above variable data of, and the above entity I i A method in which the modified data model of is calculated from the data model of the therapeutic treatment and from the indication data associated with taking the therapeutic treatment or performing the therapeutic treatment act. Claim 3 In claim 1 or 2, object I in the target window i A method in which the above positioning data represents time information regarding taking the next therapeutic treatment or performing the next therapeutic treatment act following the above therapeutic treatment. Claim 4 In claim 1 or 2, by the first device (2), object I in the target window of the therapeutic treatment i A step of calculating the maximum time to be respected for taking the next therapeutic treatment or performing the next therapeutic treatment act from the above positioning data, and / or object I in the target window of the above therapeutic treatment i A method comprising further including the step of calculating the minimum time to be observed before taking the next therapeutic treatment or performing the next therapeutic treatment act from the above positioning data. Claim 5 In claim 1 or 2, by the first device (2), object I in the target window of the therapeutic treatment i A step of calculating the maximum buffer time to be observed for taking the next therapeutic treatment or performing the next therapeutic treatment action from the above positioning data, and / or object I in the target window of the above therapeutic treatment i A method comprising further including the step of calculating a minimum buffer time to be observed before taking the next therapeutic treatment or performing the next therapeutic treatment action from the above positioning data. Claim 6 In claim 1 or 2, object I in the target window i The above positioning data represents at least one piece of data selected from a group including the following: - time of taking a therapeutic treatment, time of performing a previous therapeutic treatment act, - entity I i Response from a pharmacological model of a specific therapeutic treatment, - maximum time before the response from the specific therapeutic treatment falls below the minimum threshold of the target window, - minimum time to ensure that the response from the specific treatment does not exceed the maximum threshold of the target window. Claim 7 A method according to claim 6, wherein the positioning data indicates at least one time interval buffer Tmax before the response of a predetermined therapeutic treatment falls below a minimum buffer threshold of a target window; and / or the positioning data indicates at least one time interval buffer Tmin such that the response from the predetermined therapeutic treatment does not exceed a maximum buffer threshold of a target window. Claim 8 A method according to claim 1 or 2, further comprising the step of excluding, by means of the first device (2), the first indicator data received from the electronic monitoring device (4) from the set of indicator data associated with taking the therapeutic treatment or performing the therapeutic treatment. Claim 9 A method according to claim 1 or 2, further comprising the step of displaying at least one piece of data by an information device or a display device (5). Claim 10 In claim 1 or 2, the indication data associated with taking the prescribed therapeutic treatment or performing the therapeutic treatment act includes a time stamp and a dosage, and the method is: - by the electronic monitoring device (4), individual I i a step of recording a time stamp and dosage associated with taking the above therapeutic treatment or performing the therapeutic treatment act; - by the first device (2), object I from the data model of the above therapeutic treatment i Modified data model and object I i A method comprising the step of calculating a time stamp and dosage associated with taking the above-mentioned therapeutic treatment or performing the therapeutic treatment act. Claim 11 In claim 1 or 2, the above entity I i The modified data model of is repeatedly re-determined with each time stamp of taking a therapeutic treatment or performing a therapeutic treatment act received by the electronic monitoring device (4), and in each iteration, the entity I i Another modified data model of is, at the time of taking the last therapeutic treatment or performing the therapeutic treatment act, object I of the last iteration j i A method determined based on the modified data model of and the data model of the therapeutic treatment or the expected data model of the object. Claim 12 Object I including the following i A system (1) intended to support taking therapeutic treatment or performing therapeutic treatment actions for: - a database (3) having a data model of the therapeutic treatment, - entity I i an electronic monitoring device (4) for recording a time stamp associated with taking the above therapeutic treatment or performing the therapeutic treatment act, - from the data model of the above therapeutic treatment and object I i Entity I for calculating the modified data model of Entity Ii from the timestamp associated with taking the above therapeutic treatment or performing the therapeutic treatment act i A first device (2) for calculating positioning data of object Ii in the target window of the therapeutic treatment from the above modified model, and / or for calculating time information for taking the next therapeutic treatment or performing the next therapeutic treatment act of the above therapeutic treatment, - object I in the target window of the therapeutic treatment i An information device that provides positioning data of and / or positioning data of time information regarding taking the following therapeutic treatment or performing the following therapeutic treatment act. Claim 13 In paragraph 12, the system (1) is such that the first device (2), the information device, and the electronic monitoring device (4) are integrated into a single case. Claim 14 In paragraph 12, the electronic monitoring device (4) and the information device are integrated into a separate case from the first device (2), in a system (1). Claim 15 In claim 12, the electronic monitoring device (4), the information device, and the first device (2) are integrated into a separate case, in a system (1). Claim 16 In claim 12, the first device (2), the database (3), the information device and the electronic monitoring device (4) include a communication unit and are connected by a communication method via wireless communication or can be physically connected for data exchange, in a system (1). Claim 17 A system (1) wherein, in any one of claims 12 to 16, the electronic monitoring device (4) comprises at least one power source, at least one sensor, at least one processor, at least one clock, at least one communication unit, and at least one memory, and the electronic monitoring device (4) is configured to generate associated display data of a predetermined therapeutic treatment or therapeutic treatment act, including a time stamp, a dosage, and a history of taking a therapeutic treatment or performing a therapeutic treatment act. Claim 18 A computer program stored on a medium comprising parts of software code for implementing the following steps when the program is executed on a processor (2): - a step of obtaining a data model of a therapeutic treatment from a database (3) by the processor; - by the processor, object I i a step of receiving a time stamp associated with taking the above therapeutic treatment or performing the therapeutic treatment act from an electronic monitoring device (4), - by a processor, from a data model of the above therapeutic treatment and entity I i Entity I from the above indication data associated with taking therapeutic treatment or performing therapeutic treatment acts i Step of calculating the modified data model of; - the above entity I i Object I in the target window of the aforementioned predetermined therapeutic treatment, by the processor from the modified model of i A step of calculating positioning data of and / or a step of calculating time information for taking the next therapeutic treatment of the above therapeutic treatment or performing the next therapeutic treatment act. Claim 19 A computer program product that stores the computer program described in paragraph 18. Claim 20 Object I including the following steps i A method for supporting taking therapeutic treatment or performing a therapeutic treatment act for: - obtaining a data model of therapeutic treatment or a series of pharmacological models for at least one predetermined indication from a database (3) by the first device (2); - by the electronic monitoring device (4), individual I i A step of recording indication data associated with taking the aforementioned prescribed therapeutic treatment or performing the therapeutic treatment act, including a timestamp of; - a step of receiving the indication data associated with taking the said therapeutic treatment or performing the therapeutic treatment act from the electronic monitoring device (4) by the first device (2); - the first device (2) from the data model of the said therapeutic treatment and from the indication data associated with taking the said therapeutic treatment or performing the therapeutic treatment act the entity I i A step of calculating a modified data model of; - a step of calculating and / or displaying time information for taking the next therapeutic treatment or performing the next therapeutic treatment act by the first device (2).

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