Methods used to assist in receiving or conducting therapeutic treatment

Abstract

The present invention relates to assisting an individual I i in receiving or undergoing a therapeutic treatment, to a system (1), and to a computer program product for implementing the same.

Description

Technical Field

[0001] The present invention relates to a method for assisting individuals i Receiving or performing therapeutic treatment, and systems and computer program products for accomplishing the same. Background Art

[0002] The term receiving or undergoing therapeutic treatment, in the sense of the present invention, means that an individual i Performed by health professionals for individuals facing illness i Prescribed sets of actions in order to help them heal, relieve their symptoms or also prevent them from occurring.

[0003] More specifically, receiving therapeutic treatment may be taking an active substance, such as a curative, palliative or preventive drug. Taking an active substance, such as a food, nutrient, oligonucleotide, sugar, vitamin, may also be considered, as long as the effect and / or effectiveness of the active substance is measurable.

[0004] More specifically, a therapeutic treatment action can be a physical action, a physiological action or the use of a medical device, analogously associated with taking a drug, as long as the effect and / or effectiveness of the action is measurable. An example of a therapeutic action is exposure to light within the scope of phototherapy, for example in the case of skin lesions, as long as the melanin rate, the size of the skin lesions can be monitored to measure the effectiveness or effect of the treatment.

[0005] By taking medication, this means, for example, taking insulin within the treatment range for diabetes, the effect of which can be monitored by measuring the glucose in the blood.

[0006] By taking food, nutrients, oligonucleotides, sugars, vitamins, this means, for example, taking iron within the scope of treating anemia, the effect of which can be monitored by measuring the hemoglobin rate in the blood.

[0007] Patient compliance with dosing regimens for treatments is a growing concern today. The dosing regimen for a treatment prescribed to a patient, also known as posology, is defined by the recommended dose to be taken or administered and how often it is taken or administered.

[0008] It is known that when a treatment is carried out, in the case of drugs, foods, nutrients, oligonucleotides, carbohydrates, vitamins, the active ingredient is absorbed, distributed, metabolized and processed by the patient, and depending on the continuous administration of the treatment, over time, then the concentration of the active ingredient in the plasma, saliva, urine, tissues, blood, capillaries, etc. increases or decreases.

[0009] The dosing regimen is generally intended to maintain the concentration of the active ingredient within the therapeutic interval (plasma, saliva, urine, tissues, blood, capillaries, etc.), also called the therapeutic window, i.e. within the region of concentration of the active ingredient that ensures a therapeutic effect, such as optimal cure, palliation or prevention, while minimizing the risk of side effects. The dosing regimen is intended not to fall below a minimum concentration that corresponds to an underdose for the patient, which would lead to an increased risk of therapeutic or prophylactic failure, and is intended not to exceed a maximum concentration of the active ingredient for the patient, which would correspond to an overdose, which would lead to an increased risk of toxicity.

[0010] Furthermore, in some cases, the dosing regimen is designed to achieve very high concentrations of the active ingredient (plasma, saliva, urine, tissues, blood, capillaries, etc.) for a short period of time, i.e., a peak, in order to group side effects felt by the patient over a more limited time, or to produce a defined effect on the body, such as blocking certain transmitters or inhibitors.

[0011] Therefore, the therapeutic window can vary over time, particularly with temporary peaks in high concentrations after each treatment cycle or during rest periods.

[0012] It is estimated that more than 50% of patients do not adhere or barely adhere to their treatment, leading to recurring problems of under- and overdosing. These figures are increasing with the aging population, with the increase in the number of chronic diseases worldwide, and with the combination of multiple diseases in the same patient, leading them to take multiple medications, which often have different dosing regimens.

[0013] In the case of treatment that includes one or more therapeutic actions, the effects of the treatment may vary over time depending on the method of action of the treatment.

[0014] The frequency of therapeutic behaviors is intended to maintain the effects of the therapeutic treatment within the treatment's window of effectiveness, ie, between underexposure to the behaviors that render the treatment ineffective and overexposure to the behaviors that render the treatment potentially dangerous.

[0015] It is important that the patient sees the effects of the therapeutic treatment. In fact, for receiving or conducting a therapeutic treatment, there are effects associated, which are directly recognizable to the patient, such as the sensation of pain, or which are not directly recognizable, such as the concentration of the active substance of the therapeutic treatment.

[0016] The effects associated with each receipt or administration of a therapeutic treatment can be measured and / or identified by concentrations (plasma, saliva, urine, tissue, blood, capillaries, etc.), biomarkers, measurable or calibrated therapeutic effects (e.g., calibration of pain thresholds).

[0017] For example, when a patient receives light therapy, a relevant effect that is directly identifiable to the patient is an improvement in their mood or a reduction in skin lesions. In the case of skin lesions, a relevant effect that is not directly accessible to the patient is the regulation of the amount of melanin in the body after therapeutic treatment with light therapy. In the case of an improvement in their mood, a relevant effect that is not directly accessible to the patient is the regulation of the amount of melatonin in the body after therapeutic treatment with light therapy.

[0018] Furthermore, when patients receive pain relief treatment, a relevant effect directly recognizable to them is the reduction of their pain, which can therefore be calibrated to the pain threshold. Furthermore, a relevant effect not directly accessible to the patient is the increase in the amount of active substance, which can suppress pain in the body after the therapeutic treatment.

[0019] By therapy compliance this means, in the sense of the present invention, on the one hand persistence making it possible to define the duration for which patients continue to receive their therapy and, on the other hand implementation making it possible to characterize the way in which committed patients manage and implement their therapy day after day.

[0020] For example, a patient may follow their treatment regularly without omissions, i.e., take the treatment to the maximum extent possible. However, a patient may omit doses, delay / advance doses, take additional doses, or discontinue their treatment prematurely, in the latter case, which corresponds to non-persistence.

[0021] Furthermore, for example in the case of chronic diseases, it is possible that patients receive their treatment for several years, i.e. they adhere to the treatment. However, taking into account their daily life, patients allow themselves to implement it suboptimally, i.e. they allow themselves to intentionally or unintentionally stagger the time of receiving treatment in terms of dosage, not receive some isolated treatments, not receive some continuous treatments, or not receive treatment times corresponding to treatment holidays.

[0022] Patients may also not follow posology with respect to dosing because they take only some of the dose provided by the treatment or because they take more dose than the treatment provides.

[0023] Furthermore, adherence to therapy is influenced by numerous parameters, such as those cited in the article: Adherence to therapy in chronic patients: concepts in outpatient care, Swiss Rev. Med. 2013; Vol. 9, pp. 1032-1036:

[0024] - a sense of personal effectiveness,

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

[0026] - Patients' expectations of treatment,

[0027] - the perceived benefits of treatment,

[0028] -Barriers and facilitators.

[0029] In any case, the advantages of optimal adherence to therapy for curative, palliative or preventive treatments seem, in theory, obvious for the individual, the patient's health, and for maintaining the economic balance of health care.

[0030] Indeed, it is easy to argue that respecting a patient’s dosing regimen depends on numerous factors, whether they are intended or not.

[0031] Furthermore, it is easy to observe and recognize that patients are not robots to whom the same thing happens every day. Rather, patients are subject to numerous "life accidents", such as the need to sleep, eat, professional or non-professional activities. Furthermore, if obstacles such as side effects arise, the patient's reluctance to accept the prescribed treatment can lead to a delay in one or other of the treatments they receive or undergo for comfort, to bear the side effects at a more appropriate place or time than another. Furthermore, this is even more effective when considering that patients are sick individuals, sometimes within the range of difficult treatments, and they are more susceptible to "life accidents" such as the need to rest or avoid exposure to side effects to give them a little comfort.

[0032] Additionally, many individuals have difficulty developing an accepting style, especially when they have cognitive issues.

[0033] Patients on treatment frequently deviate from the prescribed dosing regimen not only in everyday practice, but also in the case of treatments tested in the course of clinical studies. More specifically, for treatments with a narrow therapeutic window, such as anti-rejection treatments or anticoagulants, it is important to take medication regularly, which involves remembering the time that has passed since the last dose. Regularity in taking medication is a key factor for the success of the treatment. In addition, there are numerous reminder devices that theoretically help patients remember that they must take their therapeutic treatments.

[0034] However, it is important to be able to identify a causal relationship between the receipt or application of a therapeutic treatment, between irregularities in the receipt or application of a therapeutic treatment, and, for example, the success or failure of a treatment or the occurrence of side effects. Thus, identification of a causal relationship should make it possible to adjust or not adjust the patient's dosimetry in the case of treatment, or to adjust or not adjust the dosimetry if the drug under investigation is to be marketed or to accept or not accept actions to change the patient's behavior.

[0035] Some devices can provide a level of compliance with prescribed treatments and assist when receiving treatment. Summary of the invention

[0036] The present invention belongs to this context and relates to a method for assisting an individual I i Methods of receiving or conducting therapeutic treatment, including:

[0037] - acquiring, by the first device, therapeutic treatment data from a database, such as a series of drug dosing patterns for at least one predetermined indication, and a target window for each predetermined therapeutic treatment;

[0038] - Obtaining personal I from the first device i Specific data, including:

[0039] a) Personal I i Variable data were selected in dose groups, dosimetry groups, and theoretical time groups for each scheduled therapeutic treatment.

[0040] - the first device according to the series of drug dosage patterns and personal I i The variable data of the individual i Calculation of the projection data model.

[0041] The object of document WO 2015 / 006033 is a method for assisting in selecting a dosage for a given individual.

[0042] In methods such as those described above, the system obtains a drug dosing model through treatment, more specifically, obtains a drug kinetic model and a target window for treatment, more specifically, obtains a therapeutic window.

[0043] Therefore, the medical staff selects the pharmacokinetic profile that is closest to the individual I from a sample of patients based on their specific data (individual variable data, variable data of the prescribed dose, variable data of the prescribed dosimetry, theoretical time for carrying out the treatment). i Personal I i .

[0044] The method according to this document is intended for use by medical personnel (e.g. doctors) and allows doctors to adjust personal I i In fact, the method according to this document is not intended to be specific to patients, individuals, i , and therefore have no impact on their treatment and cannot be directly managed with intervention from healthcare professionals.

[0045] US2004 / 193446 describes monitoring individuals to take medication via an electronic device that sends a signal to the individual when they forget to take their medication.

[0046] Unfortunately, current devices provide static information that estimates past effects based on the effects of treatments that have occurred, and this information is based on theoretical behavior, such as prescriptions issued by medical professionals, such as prescription models calibrated using patient information and parameters. In addition, current devices provide information to medical professionals that can redefine better dosimetry for patients.

[0047] Therefore, it is observed that the model sometimes does not correspond to reality, indeed in fact it is not possible to obtain a model based on blood concentration measurements obtained on patients. The model does not take into account the changes in concentrations due to incomplete compliance, and it is not possible to make the concentration data calculated from the model correspond to the observed / measured concentrations, even after the correction obtained by the transformation of the model.

[0048] There is a need for a device that provides information at each moment t, present or future, that takes into account the life events of a given individual, but also provides information on improving the patient's treatment compliance, i.e. regularity of treatment, but also participation, the patient's seriousness about the consequences of deviations from the dosing regimen.

[0049] The present invention aims to solve the above problems by providing a first method to help individuals i Receiving or conducting therapeutic treatment, as described at the outset, is characterized in that it further comprises:

[0050] - obtaining, by the first device, from a database a data model of the therapeutic treatment, such as a series of drug dosage models for at least one predetermined indication, and a target window for the therapeutic treatment;

[0051] - Through electronic monitoring equipment and personal I i a record of indicative data associated with receiving or carrying out said therapeutic treatment, the record including in particular personal I i timestamp;

[0052] - The first device receives information from the electronic monitoring device related to the personal I i said indicative data associated with receiving or undergoing said therapeutic treatment;

[0053] - performing, by the first device, a personal I from said data model relating to the therapeutic treatment and from said indicative data associated with receiving or performing said therapeutic treatment i Calculation of the corrected data model;

[0054] - by the first device according to the personal Ii The calibration model and the acceptance or calculation of the indicative data by the individual I i Positioning data within the target window of the predetermined therapeutic treatment, and / or time information calculated and / or indicated by the first device for next receiving or performing the therapeutic treatment.

[0055] Personal I i Positioning within the target window of the therapeutic treatment or time information for receiving or performing the next therapeutic treatment allows an individual to better plan to receive or perform the next therapeutic treatment, which makes compliance with treatment simpler and more flexible, making it more effective.

[0056] The present invention also aims to provide a method for assisting an individual I i The second method of receiving or conducting therapeutic treatment to solve the above problem is characterized in that it further comprises:

[0057] - receiving, by the first device, indicative data associated with said predetermined therapeutic treatment, including in particular timestamps, dosages and history of receipt or administration by an electronic monitoring device;

[0058] - by the first device according to the personal I i The projection data model and the indicative data associated with receiving or performing the predetermined therapeutic treatment calculate the individual I i Corrected data model;

[0059] - by the first device at each time t from the individual I i The corrected data model and the indicative data associated with receiving or performing the therapeutic treatment calculate the individual I i A personalized data model that takes into account the value of the effect at each time t, for individual I i the values ​​of all or some of the previously received or scheduled therapeutic treatments, the timestamps of receipt or administration, and the doses previously received or administered;

[0060] - Calculated by the first device from the personal I i The personalized model of the individual I in the target window of the predetermined therapeutic treatment i The target window comprises minimum and / or maximum thresholds, such as a predetermined loss of effectiveness threshold and / or a predetermined toxicity threshold.

[0061] According to the present invention, the method transforms past statistics to explain differences in treatment effects relative to prior art pharmacokinetic models and to account for differences relative to prescribed dosimetric treatments / regimens. i The personalized model corresponds to reality because it takes into account indicative data related to receipt or administration of the therapeutic treatment, including timestamps, actual or assumed doses, and history of receipt or administration, but also takes into account the data used for the individual I i The value of the residual amount of the intended therapeutic treatment.

[0062] According to the present invention, the database includes therapeutic treatment data, such as a series of drug dosage models for at least one predetermined indication (e.g., pharmacokinetic and / or pharmacodynamic and / or pharmacoeconomic and / or any other available drug dosage model), and a target window for each predetermined therapeutic treatment (e.g., a therapeutic window and / or an effectiveness threshold to be achieved and / or a toxicity threshold not to be exceeded and / or a cost / effectiveness window and / or any other target window, which may also vary over time), which are stored and recorded in the database, possibly for individual I i The parameters are recorded in the database, which may be personal I i The concentration data of is recorded in the database, more specifically, the variable data of individual Ii is recorded in the database.

[0063] In addition, the method according to the present invention includes obtaining, by the first device, the personal I i The specific data of the individual I includes a physiological panel of genetic markers (e.g., weight, age, sex) selected from the biomarkers for the individual I i Parameters of the drug dosing model.

[0064] The method according to the present invention further comprises obtaining, by the first device, the personal I i Specific data including measured effects of treatment, measured concentrations, side effects, estimated half-life, estimated duration of action, cost / benefit ratio, group selection for individual I i of medical data.

[0065] The method according to the present invention further comprises: the first device according to the user for the personal I i The parameters of the drug dosing model and / or individual I i The medical data of the individual i Projection data model or personal I i Corrected data model or personal I i Calculation of personalized data models.

[0066] In fact, it seems particularly advantageous that the first device according to the invention is used in conjunction with a device for personal Ii Parameters of the drug dosing model and / or individual I i The acquisition of medical data enables the calculation of a projection data model or a corrected data model or a personalized data model close to reality. In fact, the more personal I i Specific data of personal i The projected data model or the corrected data model or the personalized data model will be more accurate and complete.

[0067] Furthermore, the first device may include one or more databases. In fact, it may include a first database comprising therapeutic treatment data, such as a series of drug dosing models, for example pharmacokinetics and / or pharmacodynamics and / or pharmacoeconomics for at least one predetermined indication, and a target window for each predetermined therapeutic treatment (which may vary over time).

[0068] The first device may include a second database including the personal I i specific data, such as: a) selected from a physiological panel of biomarkers, genetic markers, and specific data for an individual i b) select individual I from the group of measured therapeutic effects, measured concentrations, side effects, estimated half-lives, estimated durations of action, cost / benefit ratios i and c) selecting individual I from a group of doses, dosimetry, and time for theoretically receiving each scheduled therapeutic treatment i Variable data.

[0069] The first device may include a third database comprising data of the therapeutic treatment, such as a series of drug dosage models, such as pharmacokinetic and / or pharmacodynamic and / or pharmacoeconomic for at least one predetermined indication, and a target window for each predetermined therapeutic treatment and a personal I i Specific data for an individual: For example: a) selected from a biological panel of genetic markers (e.g., weight, age, sex) for an individual i b) parameters of the drug dosing model of the drug; b) individual I selected from the group of measured therapeutic effect, measured concentration, side effects, estimated half-life, estimated duration of action, cost / benefit ratio i and c) individual I selected from the group of doses, dosimetry, and time for theoretically receiving each scheduled therapeutic treatment i Variable data.

[0070] According to the invention, the first device receives from the electronic monitoring device indicative data associated with the receipt or performance of a predetermined therapeutic treatment, these indicative data comprising in particular a time stamp, for example actual or assumed doses and a history of the receipt or performance of the treatment.

[0071] Then, the first device can i The projection data model and the indicative data associated with receiving therapeutic treatment are used to calculate the individual I i A corrected data model that represents the effect of therapeutic treatment on patients over time, considering the individual I i Medical data relating to assimilation, distribution, metabolism and / or elimination and / or measured therapeutic effects and / or measured concentrations and / or side effects and / or estimated half-life and / or estimated duration of action, as well as dates, times, doses and history of receipt or administration of therapeutic treatments.

[0072] Personal I i Calculation of a corrected data model makes it possible to provide a model that takes into account differences from traditional drug dosing models and differences from receiving or taking prescribed treatment, taking into account the history of actual receipt or taking of therapeutic treatment.

[0073] In fact, using conventional pharmacokinetic models of the prior art, peaks or troughs in measured therapeutic effects can only be explained by changes in the patient's pharmacokinetic parameters, such as absorption, distribution, metabolism and / or elimination.

[0074] According to the invention, when a peak in therapeutic effect is observed in the model, e.g., when a peak in the concentration of the active substance of the therapeutic treatment is observed, it will not be attributed to rapid assimilation if it coincides with the event of receiving or taking the therapeutic treatment, but can be explained as a result of receiving or taking the treatment. A trough in the efficacy of the model, e.g., a trough in the concentration, can be explained by the omission of receiving or taking the therapeutic treatment rather than by its rapid removal if it coincides with the event of not receiving or taking the therapeutic treatment for a period of time.

[0075] Therefore, since the individual adjusted data model takes into account the indicative data associated with receipt of therapeutic treatment, it is possible to explain the differences rather than attributing the changes in effect to erroneous causes.

[0076] For this reason, differences in therapeutic efficacy or side effects of therapeutic efficacy can be directly attributed to problems with patient compliance with treatment, rather than simply to problems related to patient physiology, such as variations in absorption, distribution, metabolism or elimination, or to problems related to therapeutic treatment.

[0077] The electronic monitoring device includes a power supply, a sensor, a processor, a communication unit, a clock and a memory. The above elements can be included in one or more electronic devices. i When receiving or performing therapeutic treatment, the sensor of the electronic monitoring device is automatically activated or not automatically activated, for example, in the case of a button, the sensor on the individual I i The action of receiving or administering a treatment is recorded as an event of receiving or administering a treatment. The processor is arranged to process the event of receiving or administering a therapeutic treatment and generate a signal including indicative data associated with receiving or administering a therapeutic treatment. These indicative data include a timestamp, an actual or hypothetical dose, and a history of receiving or administering a treatment. In fact, the processor records the indicative data associated with receiving or administering a therapeutic treatment in a memory of the electronic monitoring device, which also records the indicative data associated with the dispenser dispensing the drug or administering the therapeutic treatment.

[0078] By electronic monitoring device, in the sense of the present invention this means for example a package, box, container for medication, embedded (or non-embedded) dispenser comprising an electronic monitoring device, which also means a package, box, container for medication, embedded (or non-embedded) dispenser, connected via a smartphone application, tablet or smartwatch, or any other electronic recording device, arranged to generate a signal comprising indicative data associated with receiving or taking a therapeutic treatment. This also means any other recording device allowing a patient to state that they have received or taken their therapeutic treatment, such as a register.

[0079] According to the present invention, the first device at each time t, now or in the future, based on the personal I i The corrected data model and indicative data associated with receiving or undergoing therapeutic treatment are used to calculate the individual I i Personalized data model.

[0080] In fact, according to the present invention, individual I i The personalized data model takes into account the i The first device according to the invention calculates at each instant t the value of the effect of all or some of the previous effects of the receipt or performance of a predetermined therapeutic treatment, i.e. the proportion of the therapeutic treatment that has not been removed, for example the proportion of the active substance used for the therapeutic treatment of the individual that has not been removed. Based on a data model for the individual correction taking into account the values ​​of the residual amounts and the doses previously received or performed, the first device according to the invention calculates at each instant t now or in the future the data and timestamp associated with the receipt or performance of the treatment that has not been removed, the personal I i Personalized data model.

[0081] According to the invention, the first device calculates at each moment the individual I within a predetermined target window of therapeutic treatment based on a personalized model of the individual and indicative data associated with receiving or performing therapeutic treatment. i Positioning data.

[0082] In fact, the first device makes it possible to predictively calculate the changes over time in the concentration and / or the effect of another therapeutic treatment received or carried out, and taking into account the individual I i An estimate of the value of the effect of all or some of the therapeutic treatments previously received or scheduled at each time instant t.

[0083] The target window, which may vary over time, may at any time include minimum and / or maximum thresholds, such as a loss of effectiveness threshold and / or a toxicity threshold, both of which are predetermined.

[0084] It is particularly advantageous that, according to the invention, the personal I can be calculated by the first device. i Positioning data within the target window (therapeutic window and / or effectiveness threshold achieved and / or toxicity threshold not exceeded and / or cost / effectiveness window and / or any other target window). These positioning data take into account the individual I i and indicative data associated with receipt or performance of therapeutic treatments, and for individuals while accounting for differences in treatment adherence i Is personalized thanks to indicative data associated with receiving or conducting therapeutic treatments.

[0085] In fact, the first device according to the invention advantageously makes it possible to enable a given individual I to i , patients consciously realize the importance of regularity of therapeutic treatment, that is, to achieve optimal treatment compliance by positioning their treatment effect in the target window at each moment t in the present or future. i It can be determined at each time instant t now or in the future whether it is approaching a toxicity threshold and / or an effectiveness loss threshold and / or an effectiveness threshold to be reached and / or whether it is positioned in a cost / benefit window or any other target window.

[0086] The device according to the invention can also enable individuals I to achieve the therapeutic effect of their treatment by materializing it in a target window at each moment t in the present or future. i , patients are aware of the impact of treatment compliance on the therapeutic effect of treatment. In fact, it is important for patients to see the relationship between treatment compliance, treatment effect and the effectiveness of treatment.

[0087] When this information is made available to healthcare professionals, it can subsequently identify patients, individuals,i Rather than facing a problem of assimilation, distribution, metabolism and / or elimination, one is facing a problem of treatment compliance. In this case, the solution is not to overdose the therapeutic treatment (e.g., drug) to avoid increased toxicity, or to alter the therapeutic treatment molecule, but to understand the reasons for this behavior and educate the patient on good treatment compliance.

[0088] In a preferred embodiment of the present invention, the method further comprises: i The positioning data are used to calculate the time interval Tmin to be observed before the next therapeutic treatment is received or performed.

[0089] In another preferred embodiment of the present invention, the method further comprises: i The positioning data within the target window of the predetermined therapeutic treatment calculates the time interval Tmax to be observed before the next therapeutic treatment is received or performed.

[0090] It seems particularly advantageous that the time interval Tmin to be observed before the next receipt of a therapeutic treatment and / or the time interval Tmax to be observed for the next receipt of a therapeutic treatment are calculated by the first device, making it possible to provide the patient with accurate and simple information about the future of their treatment regimen (i.e. the time interval between Tmin and Tmax within which the next receipt or the next therapeutic treatment must occur).

[0091] The calculation by the first device of the time interval Tmin to be observed before the next receipt of the therapeutic treatment makes it possible to provide information about the minimum time before which the patient, the individual I i You may not receive or undergo therapeutic treatment that would result in the effects of treatment (e.g., i The concentration of the active substance) does not exceed a maximum threshold value (e.g. a predetermined toxicity threshold value).

[0092] The calculation by the first device of the time interval Tmax to be observed for the next receipt or administration of a therapeutic treatment makes it possible to provide information about the maximum time before which the patient, the individual I i Therapeutic treatment must be received or performed such that the therapeutic effect (eg the concentration of the active substance in the body) does not fall below a minimum threshold (eg a predetermined loss of effectiveness threshold).

[0093] Indeed, in both cases, the exceeding of the therapeutic effect (e.g. the concentration of the active substance) above the toxicity threshold or below the loss of effectiveness threshold is undesirable and it is important for the success of the treatment to minimize the exceeding of the critical thresholds and to minimize the risk of adverse reactions. iThe concentration of the active substance is positioned in the target window.

[0094] Instead of giving information about the past or a score about the patient's history of treatment compliance, according to the invention the first device gives a number of hours and / or minutes (whether integer or non-integer) to be observed, in the future:

[0095] - Before the next therapeutic treatment is received or carried out, the effect of the treatment (e.g. for personal I i The concentration of the active substance does not exceed the predetermined toxicity threshold, time interval Tmin,

[0096] – Before the next therapeutic treatment is received or carried out, the effect of the treatment (e.g. for personal I i The concentration of the active substance) is not lower than the predetermined effectiveness loss threshold, time interval Tmax.

[0097] Therefore, the method according to the present invention assists individuals i , so that it optimizes the effectiveness of their therapeutic treatment by guiding their future receipt or conduct of therapeutic treatment rather than by providing them with a single indication of the past effects of treatment (anyway, it is too late to act now).

[0098] For example, this allows a patient to receive light therapy treatment to improve their mood, knowing that it will last with them, for example, 20 hours, 18 hours, 15 hours, 12 hours, 10 hours, 8 hours, 5 hours, 2 hours before the melatonin rate in their body falls below a threshold of loss of effectiveness and their mood worsens.

[0099] Furthermore, for patients receiving analgesic active substances, this allows them to know that their pain returns before the rate of active substance suppressing pain in their body falls below a threshold of loss of effectiveness (eg 5 hours).

[0100] Advantageously, the method according to the invention further comprises: i The positioning data is calculated for at least one time interval "buffer Tmin" before the next treatment is received or performed.

[0101] Advantageously, the method according to the invention further comprises the step of: providing, by the first device, a treatment plan for the individual I within the target window of the predetermined therapeutic treatment; i The positioning data is used to calculate at least one time interval "buffer Tmax" for the next treatment to be received or performed.

[0102] The conventional target window (eg, therapeutic window) includes three regions: the optimal region, where the therapeutic effect (eg, individual Ii The concentration of the active substance) must be such that the treatment produces the desired, curative, palliative, or preventive effect; a toxicity zone within the optimal zone defined by a predetermined toxicity threshold; a loss of effectiveness zone within the optimal zone defined by a loss of effectiveness threshold.

[0103] It appears to be particularly advantageous according to the present invention to provide a target window, such as a therapeutic window having five regions including the three previous regions and also including a minimum buffer region, such as loss of effectiveness, and a maximum buffer region, such as toxicity.

[0104] The loss of effectiveness buffer zone is usually based on the concept of therapeutic absolution, making it possible to foresee an excess of the therapeutic effect, for example, for the concentration of the active substance for an individual in the loss of effectiveness zone.

[0105] The toxicity buffer zone makes it possible to foresee an excess of the therapeutic effect, for example the concentration of the active substance for an individual in the toxicity zone.

[0106] According to the invention, it appears advantageous that the calculation of the time interval buffer Tmin and / or the time interval buffer Tmax by the first device makes it possible to give the patient more flexibility and comfort in managing their therapeutic treatment.

[0107] Furthermore, the validity loss and toxicity buffer zones can be modifiable on the one hand and dynamic on the other.

[0108] In fact, these buffer zones can be modified based on the patient's feelings. For example, a patient who feels significant side effects after receiving or undergoing a therapeutic treatment can decide on their own or through a rehabilitation care professional to modify the toxicity buffer zone to reduce the feeling of side effects.

[0109] Additionally, it is important to get patients into the habit of receiving or doing therapeutic treatments, and to do this, having dynamic buffer zones is essential. The goal is to initiate a narrow optimal zone (i.e., with a significant buffer zone for toxicity and a significant buffer zone for loss of effectiveness) for the patient (the goal is to force the patient into the habit of receiving or doing therapeutic treatments). Once the patient has developed the habit of receiving or doing therapeutic treatments, the buffer zones for toxicity and loss of effectiveness are reduced, limited, and the optimal zone becomes larger, providing more comfort and flexibility in managing their therapeutic treatments.

[0110] In another embodiment, the method according to the present invention further comprises: i The positioning data is used to calculate at least one second time interval buffer Tmin before the next treatment is received or performed and / or the individual I is calculated according to the target window of the predetermined therapeutic treatment.i The positioning data is used to calculate at least one second time interval buffer Tmax for the next treatment received or performed.

[0111] Furthermore, the buffer zones exist regardless of the patient and include characteristics of the drug, and these buffer zones can be adjusted by the patient or by the healthcare professional, with or without preventive modifications, and treatment can be accepted or taken based on the advice provided by the healthcare professional.

[0112] Advantageously, the target window contains individual I i The positioning data indicates at least one piece of information selected from the group consisting of:

[0113] – the duration of the previous behavior receiving therapeutic treatment,

[0114] -Personal I i The response of the pharmacotherapy model to the intended therapeutic treatment,

[0115] - the time Tmax before the response of the predetermined therapeutic treatment falls below said minimum threshold of the predetermined target window,

[0116] - The time Tmin such that the response of the predetermined therapeutic treatment does not exceed said maximum threshold of the predetermined target window.

[0117] Advantageously, the positioning data further indicates at least one time interval buffering Tmax before the response of the predetermined therapeutic treatment falls below a minimum buffering threshold of the target window.

[0118] Advantageously, the positioning data further indicates at least one time interval buffering Tmin such that the response of the predetermined therapeutic treatment does not exceed a maximum buffering threshold of the target window.

[0119] In fact, positioning data shows that:

[0120] The timing of prior activity in receiving therapeutic treatment allows for the patient to be provided with an indication of their history of receiving or undergoing therapeutic treatment, which is particularly important for patients who are ill, elderly, or have memory impairment.

[0121] For personal use i The effect of the predetermined therapeutic treatment makes it possible to provide the patient with information about their positioning in the target window. This further allows the patient to anticipate the hazards of their activities of daily life, for example in the case of side effects or increased fatigue. The patient has the opportunity to know where the therapeutic effect (e.g. the concentration of the active substance in their body) is located in the target window and to be able to rest, perform any activity without having to worry about the success of their therapeutic treatment.

[0122] The time Tmax and time Tmin before the response of the scheduled therapeutic treatment is below the minimum threshold of the target window, so that the response of the scheduled therapeutic treatment does not exceed the maximum threshold of the target window mentioned above. These two pieces of information also allow patients, individuals, i Better anticipation of life events (e.g. sleep, side effects, work-related travel, extra-professional activities) is very advantageous.

[0123] Indeed, providing patients with an interval buffered Tmax and / or an interval buffered Tmin allows patients to better understand their therapeutic treatment to ensure they are taking the correct dose and have greater flexibility and comfort in managing their therapeutic treatment while maintaining an optimal effect / toxicity balance.

[0124] Finally, it can be hypothesized that the proposed system could allow patients to collaborate with prescribers to manage their medications in terms of dosing and intervals between doses while optimally controlling their therapeutic effects; returning to personalized and variable posology over time.

[0125] This information allows the patient to know how much time they have before a therapeutic response, such as being in the effectiveness loss buffer zone, where the concentration of the active substance of the therapeutic treatment in their body is below the effectiveness loss buffer threshold, but also above the critical effectiveness loss zone. It is indeed advantageous, for example, to be able to inform the patient through the effectiveness loss buffer zone that if they do not receive or perform therapeutic treatment within this time frame, they have two hours left before falling into the critical effectiveness loss zone.

[0126] Furthermore, this information also allows the patient to know how much time they have so that the effect of their treatment (e.g., the concentration of the active substance of the therapeutic treatment) does not exceed the toxicity buffer zone, or is in the toxicity buffer zone. It is indeed advantageous to be able to inform the patient with the toxicity buffer zone that they must wait, for example, two hours to receive or perform a treatment or therapeutic action in order not to enter the critical toxicity zone if the therapeutic treatment is received or performed within this time frame.

[0127] This is particularly advantageous for patients who want to adjust their receipt or conduct of therapeutic treatment in case of emergencies or daily events. For example, the patient is in the optimal area of ​​the target window, and based on the data of the present invention, the patient has the opportunity to take the medication, such as taking half a tablet, or conduct the therapeutic treatment at the ideal time to stay below the critical toxicity threshold, and then the patient knows the remaining time before falling into the critical effectiveness loss area. This makes it possible to provide autonomy and comfort to the patient's therapeutic treatment and allows them to anticipate daily life events, such as work-related travel, any activities, necessary sleep time.

[0128] Additionally, healthcare professionals have the opportunity to adjust the dosage of therapeutic treatments or make treatment decisions.

[0129] In a further embodiment, the method according to the invention further comprises indicating at least one piece of data, preferably via an information device, such as a display device.

[0130] In fact, the indication of at least one piece of data is particularly advantageous, since it makes it possible to provide the patient, the individual i Provide a clear, precise and directly accessible and understandable piece of information.

[0131] Furthermore, by accessing clear, precise and understandable information representing their position in the target window, patients can therefore optimize their receipt or delivery of therapeutic treatments, for example to reduce the side effects of difficult treatments. In fact, instead of receiving a complete therapeutic treatment (e.g., a whole tablet) every 24 hours, a patient can choose to receive half a treatment (e.g., half a tablet) every 12 hours.

[0132] Advantageously, the method according to the invention further comprises sending an alarm signal, preferably a visual or auditory signal, by the first device and / or by the electronic monitoring device and / or the smart device (tablet, watch, smartphone, etc.) if the therapeutic effect at each moment t now or in the future is below a minimum threshold (e.g. loss of effectiveness), above a maximum threshold (e.g. toxicity), below a minimum buffer threshold (e.g. loss of effectiveness), above a maximum buffer threshold (e.g. toxicity).

[0133] Furthermore, it is particularly advantageous according to the invention that the information device allowing the indication of at least one piece of data, and / or the first device, and / or the electronic monitoring device, and / or the display device, and / or the smart device allowing the sending of an alarm signal, is equipped with an interface and more specifically with an intelligent personal assistance system (commonly referred to as an intelligent personal assistant, also called a virtual personal assistant). This further makes it possible to perform tasks or services for individuals by sending them information, alarms, reminders and other signals. The interface, more specifically the intelligent personal assistant, can interact with the patient, send signals, provide information by means of written communication and / or voice communication. For example, Alexa, Google Assistant, Google Now, Cortana, BlackBerry Assistant, Bixby, Siri, Viv, etc. are mentioned.

[0134] In fact, it is particularly advantageous according to the invention to be able to provide the patient with an alarm signal at each instant t now or in the future when the therapeutic effect of the interface therapy passes one of the mentioned threshold values.

[0135] Advantageously, the method according to the invention further comprises, according to the individual Ii The projection data model and the indicative data are calculated by the first device after receiving and as a minimum personal I i The personalized data model is associated with data of receiving or conducting the treatment, preferably after receipt, for a duration of at least 2 half-lives of the treatment, preferably at least 2.5 half-lives of the treatment, advantageously at least 3 half-lives of the treatment, advantageously at least 4 half-lives of the treatment, preferably at least 5 half-lives of the treatment.

[0136] In fact, the more said indicative data of receiving or carrying out a treatment are received by the first device, the more likely the individual I i The more the personalized data model is improved in accuracy and more it reflects the real situation.

[0137] For example, receiving the indicative data over the duration of one half-life of a therapeutic treatment allows calculation of the individual I i The personalized data model receives the indicative data over a duration of 2 half-lives so as to calculate the personal I i A better personalized data model is possible, receiving the indicative data over the duration of 3 half-lives of the treatment enables calculation of the individual I i The personalized data model is close to reality.

[0138] Advantageously, the method further comprises excluding, by the first device, the received first indicative data from a set of indicative data of receiving or performing a therapeutic treatment.

[0139] It seems particularly advantageous that the exclusion of the first indicative data received by the first device from the set of indicative data allows the individual I i The personalized model does not lose significant accuracy and reflects the true situation at each time instant t while optimizing the necessary computing time and the required storage space.

[0140] In fact, a predetermined number of indicative data (e.g. 1 indicative data, 2 indicative data, 3 indicative data, 4 indicative data) is excluded by the first device from receiving, for example, 10 indicative data, 9 indicative data, 8 indicative data, 7 indicative data, etc.

[0141] This advantageously makes it possible to save the most recent indicative data of the treatment received or carried out that best represent the patient's compliance behavior at the time t, in order to calculate the personal I i Personalized model.

[0142] According to the present invention, for helping individuals i Other embodiments of methods of receiving or performing therapeutic treatment are indicated in the appended claims.

[0143] The present invention also relates to a method for assisting an individual i A system for receiving or performing therapeutic treatment, the system comprising:

[0144] -First device,

[0145] -database,

[0146] - display devices,

[0147] -Electronic monitoring equipment,

[0148] It is configured to implement the steps of the method according to the invention.

[0149] It seems that it is indeed possible to use i The steps of the method according to the present invention are implemented in a system for receiving or performing therapeutic treatment, the system comprising a first device, a database, a display device and an electronic monitoring device.

[0150] In fact, the database includes data about the drug, including a series of pharmacokinetic and / or pharmacodynamic models for at least one predetermined therapeutic treatment for at least one predetermined indication, and a target window for each predetermined therapeutic treatment. The database includes a communication unit. In addition, in this database or another database, data a), b) and c) are also stored and recorded.

[0151] The electronic monitoring device includes a power supply, a sensor, a processor, a communication unit, a clock and a memory. The above elements can be included in one or more electronic devices. i When receiving or conducting therapeutic treatment, the sensors of the electronic monitoring device are automatically activated or deactivated, for example, in the case of a button, the individual I i The action on the sensor is recorded as an event of receiving or performing therapeutic treatment. The processor is arranged to process the receiving or performing therapeutic treatment and generate a signal including indicative data associated with receiving or performing therapeutic treatment. These indicative data include a timestamp, an actual or assumed dose, and a history of receiving or performing treatment. In fact, the processor records the indicative data associated with receiving or performing therapeutic treatment in the memory of the electronic monitoring device.

[0152] The first device of the system according to the invention comprises a power supply, a processor, a communication unit and a memory and is configured to implement the calculation steps of the method according to the invention based on a database and data received from an electronic monitoring device.

[0153] A display device, which may be integrated in a device, includes a power supply, a communication unit, and a processor, and is configured to be used as a personal I iProvide clear, accurate, simple, and directly accessible and understandable information.

[0154] In a preferred embodiment of the system according to the invention, the first device, the display device and the electronic monitoring device are integrated into a single housing.

[0155] In a further embodiment of the system according to the invention, the first device and said display device are integrated into a housing separate from the electronic monitoring device.

[0156] In a further embodiment of the system according to the invention, the electronic monitoring device and the display device are both integrated into a housing separate from the display device.

[0157] In a further embodiment of the system according to the invention, the first device and the electronic monitoring device are both integrated into a housing separate from the display device.

[0158] In a further embodiment of the system according to the invention, the electronic monitoring device, the display device and the first device are integrated into separate housings.

[0159] Advantageously, the system according to the invention is characterized in that the first device, the database, the display device and the electronic monitoring device comprise a communication unit and are communicatively connected by wireless communication or can be physically connected for data exchange.

[0160] Advantageously, the electronic monitoring device of the system according to the invention further comprises at least one power supply, at least one sensor, at least one processor, at least one clock, at least one communication unit and at least one memory. The above elements may be included in one or more electronic devices. The electronic monitoring device is configured to generate indicative data associated with receiving or performing a predetermined therapeutic treatment, the indicative data comprising a timestamp, a dosage and a history of receiving or performing the therapeutic treatment.

[0161] Further embodiments of the system according to the invention are indicated in the dependent claims.

[0162] The invention further relates to a computer program product comprising a program for a first device, the program comprising software code portions for implementing the steps of the method according to the invention when the program is executed on said first device.

[0163] In an advantageous embodiment, the computer program product according to the invention comprises a computer-readable medium on which the software code portions are stored, wherein the program can be directly loaded into an internal memory of the first device.

[0164] Further embodiments of the computer program product according to the invention are indicated in the dependent claims.

[0165] The present invention further relates to a method for assisting an individual i A second method of receiving or conducting therapeutic treatment, including:

[0166] - acquiring, by the first device (2), therapeutic treatment data from a database (3), such as a series of drug dosage patterns for at least one predetermined indication, and a target window for each predetermined therapeutic treatment;

[0167] – Obtain personal I through the first device (2) i Specific data, including:

[0168] a) Select individuals from the group of doses, posology, and theoretical duration of each scheduled therapeutic treatment. i Variable data of

[0169] - by the first device (2) according to the series of drug dosage models and personal I i The variable data of the individual i Calculation of the projection data model.

[0170] This second method for aiding in receiving or conducting therapeutic treatment is characterized in that it further comprises:

[0171] - receiving, by means of the first device (2), indicative data associated with receiving or carrying out said predetermined therapeutic treatment, the indicative data comprising in particular a timestamp of the electronic monitoring device (4), a dosage and a history of receiving or carrying out the therapeutic treatment;

[0172] - by the first device (2), after receiving as a minimum data associated with receiving or carrying out the predetermined therapeutic treatment, according to the individual I i The projection data model and the indicative data are used to perform personal I i Calculation of personalized data models;

[0173] - calculating, by the first device (2), at each instant t, the personal I based on indicative data associated with receiving or carrying out said predetermined therapeutic treatment i A personalized data model that takes into account all or some of the i The value of the effect of a previously received or administered scheduled therapeutic treatment at each time instant t, the timestamp of the receipt or administration, and the dose of the received or previously administered therapeutic treatment.

[0174] When an individual begins their therapeutic treatment, they perform their first receipt or administration of the therapeutic treatment and record the event of receipt or administration of the treatment in the electronic monitoring device. The patient then continues their therapeutic treatment and continues to record the event of receipt or administration of the treatment in the electronic monitoring device each time the therapeutic treatment is received or administered.

[0175] The first device receives indicative data associated with receiving or performing a predetermined therapeutic treatment and then calculates the personal I i Personalized data model.

[0176] It has been shown that, according to the present invention, it is possible to calculate the personal I by the first device i A personalized data model is provided for receiving, as a minimum, data associated with receiving or performing the predetermined therapeutic treatment.

[0177] The first device calculates the personal I at each moment t now or in the future i Personalized model, and according to individual I i The projection data model and the indicative data are in the individual I i The duration of 1 half-life of the personalized data model as a minimum limit for treatment is obtained after receiving the indicative data for the individual I i The optimal personalized model preferably lasts for at least 2 half-lives of treatment, preferably for at least 2.5 half-lives of treatment, advantageously for at least 3 half-lives of treatment, advantageously for at least 4 half-lives of treatment, preferably for at least 5 half-lives of treatment.

[0178] The therapeutic half-life in the sense of the present invention is the time it takes for an active substance, such as a molecule, a drug, an active ingredient, to lose half of its pharmacological or physiological activity.

[0179] In fact, the more said indicative data of receiving or carrying out a therapeutic treatment are received by the first device, the more likely the individual I i The more the accuracy of the personalized data model increases, the more it can reflect the real situation.

[0180] For example, receiving the indicative data over the duration of 1 half-life of a treatment allows calculation of an individual I i A personalized data model, receiving said indicative data over a duration of 2 half-lives of treatment, allows calculation of the individual I i A better personalized data model is possible, receiving the indicative data over the duration of 3 half-lives of the treatment enables calculation of the individual I i The personalized data model is close to reality.

[0181] Advantageously, the second method further comprises excluding, by the first device, the first indicative data received from a set of indicative data of receiving or performing a therapeutic treatment.

[0182] It seems particularly advantageous that the exclusion of the first indicative data received by the first device from the set of indicative data allows the individual I i The personalized model of t does not lose significant accuracy and reflects the reality at each time instant t while optimizing the necessary computing time and the required storage space.

[0183] In fact, a predetermined number of first indicative data (e.g. 1 indicative data, 2 indicative data, 3 indicative data, 4 indicative data) are excluded from receiving, e.g., 10 indicative data, 9 indicative data, 8 indicative data, 7 indicative data, and so on, by the first device.

[0184] This advantageously makes it possible to save the indicative data of the receipt or conduct of therapeutic treatment that are most recent and most representative of the patient's compliance behavior at the time t, in order to calculate the personal I i Personalized model.

[0185] In addition, the second method according to the present invention includes obtaining, by the first device, a personal I i The specific data includes a physiological group of genetic markers selected from biomarkers (e.g., weight, age, gender) for the individual I i Parameters of the drug dosing model.

[0186] The second method according to the present invention further comprises obtaining, by the first device, the personal I i The specific data include individual I selected from the group consisting of measured effect of the treatment, measured concentration, side effects, estimated half-life, estimated duration of action, cost / benefit ratio i of medical data.

[0187] The second method according to the present invention further comprises: i The parameters of the drug dosing model and / or individual I i The medical data of the individual is calculated i Projection data model or personal I i Corrected data model or personal I i Personalized data model.

[0188] It seems particularly advantageous in fact that the first device according to the invention is used for personal I i Parameters of the drug dosing model and / or individual I iThe acquisition of medical data of the individual I can be calculated more realistically. i The more specific data a person has, the more i The projected data model will be more accurate and complete.

[0189] Advantageously, the second method further comprises, by the first device, i The personalized model and the indicative data for receiving the treatment calculate the therapeutic treatment for the individual I in the target window i The target window may include minimum and / or maximum thresholds, such as a predetermined effectiveness loss threshold and / or a predetermined toxicity threshold.

[0190] In a preferred embodiment, the second method further comprises treating the individual I in the target window according to the predetermined therapeutic treatment by the first device. i The positioning data is used to calculate the time interval Tmin to be observed before the next receipt or performance of the therapeutic treatment.

[0191] In another preferred embodiment of the second method according to the present invention, the second method further comprises treating the individual I in the target window according to the predetermined therapeutic treatment by the first device. i The positioning data is used to calculate the time interval Tmax to be observed for the next reception or performance of the treatment.

[0192] It seems particularly advantageous that the calculation by the first device of the time interval Tmin to be observed before the next therapeutic treatment and / or the time interval Tmax to be observed before the next therapeutic treatment is taken makes it possible to provide the patient with accurate and simple information about the future of their treatment regimen (i.e. the time interval between Tmin and Tmax within which the next therapeutic treatment must occur).

[0193] The calculation of the time interval Tmin to be observed by the first device before the next therapeutic treatment is received makes it possible to provide information about the patient, the individual I i Information on the minimum time that a person must not have received or been treated for prior to the treatment to ensure that the treatment is effective (e.g. for personal use). i The concentration of the active substance does not exceed a predetermined toxicity threshold.

[0194] The calculation of the time interval Tmax to be observed for the next treatment by the first device makes it possible to provide information about the patient, the individual I i Information on the maximum time that treatment must have been received or carried out before such treatment can be effective (e.g. for individual I iThe concentration of the active substance) is not lower than a predetermined effectiveness loss threshold.

[0195] Indeed, in both cases, a therapeutic effect (e.g. concentration of active substance) above a toxicity threshold or above a loss of effectiveness threshold is undesirable and by limiting access to critical thresholds as much as possible, the target window for individual I i The concentration of the active substance is important for the success of the treatment.

[0196] Instead of giving a score which is information about the past or about the patient's history of treatment compliance, according to the invention the first device gives a time instruction which can be expressed, for example, in hours and / or minutes (whole or not) in the future to be observed for:

[0197] - Before the next receipt or next administration of therapeutic treatment, the treatment response (e.g., individual I i the concentration of the active substance) does not exceed a maximum threshold value (e.g. predetermined toxicity, time interval Tmin),

[0198] - for the next receipt or next administration of therapeutic treatment, so that the treatment response (e.g., for individual I i The concentration of the active substance) does not fall below a minimum threshold (e.g. a predetermined loss of effectiveness, time interval Tmax).

[0199] The second method according to the invention thus assists the individual I i Allowing them to optimize the effectiveness of their therapeutic treatments by not providing them with a single indication of past effects (in any case, it is too late to act) to guide them in accepting or undertaking future therapeutic treatments.

[0200] Additionally, for patients being treated with analgesic actives, this allows them to know that, for example, the 5 hour analgesia before the pain relief active in their body fell below the loss of effectiveness threshold was still effective and their pain returned.

[0201] Advantageously, the second method according to the present invention further comprises treating the individual I in the target window according to the predetermined therapeutic treatment by the first device. i The positioning data is used to calculate at least one time interval buffer Tmin before the next therapeutic treatment is received or performed.

[0202] Advantageously, the second method according to the present invention further comprises treating the individual I in the target window according to the predetermined therapeutic treatment by the first device. i The positioning data is used to calculate at least one time interval buffer Tmax for the next time to receive or perform therapeutic treatment.

[0203] The conventional target window (eg, therapeutic window) includes three regions: the optimal region, wherein the therapeutic effect (eg, for individual I i The concentration of the active substance) must be such that the treatment produces the desired, curative, palliative or preventive effect; the toxicity zone of the optimal zone is delimited by a predetermined toxicity threshold; the effectiveness loss zone of the optimal zone is delimited by a effectiveness loss threshold.

[0204] It appears to be particularly advantageous according to the invention to provide a target window, for example a therapeutic window having five regions, including the three previous regions and further including a buffer region for loss of effectiveness and a buffer region for toxicity.

[0205] The effectiveness loss buffer region can anticipate the therapeutic effect (eg, concentration of active substance for an individual) to decrease by entering the effectiveness loss region.

[0206] The toxicity buffer zone can anticipate the therapeutic effect (eg, concentration of active substance for an individual) by entering the toxicity zone.

[0207] According to the invention, it appears advantageous that the calculation of the time interval buffer Tmin and / or the time interval buffer Tmax by the first device makes it possible to give the patient more flexibility and comfort in managing their therapeutic treatment.

[0208] Furthermore, the validity loss and toxicity buffer zones can be modified on the one hand and dynamic on the other.

[0209] In fact, these buffer zones can be modified based on the patient's perception, for example, a patient who experiences significant side effects after receiving or undergoing a treatment can decide on their own or through a healthcare professional to reduce the toxicity buffer zone to reduce the perception of side effects.

[0210] In addition, it is important to get patients into the habit of accepting or performing therapeutic treatments, and for this, a dynamic buffer zone is necessary. The goal is to start a narrow optimal zone for the patient (i.e., with a significant toxicity buffer zone and a significant loss of effectiveness buffer zone), with the goal of forcing the patient to develop a habit of accepting or performing therapeutic treatments. Once the patient develops a habit of accepting or performing treatments, the toxicity and loss of effectiveness buffer zones are reduced, limited, and the optimal zone becomes larger, providing more comfort and flexibility in managing their therapeutic treatments.

[0211] In another embodiment, the method according to the present invention further comprises treating the individual I in the target window according to the predetermined therapeutic treatment by the first device. iThe positioning data is used to calculate at least one second time interval buffer Tmin before the next treatment is received or performed and / or the individual I in the target window of the predetermined therapeutic treatment i At least one second time interval buffer Tmax for the next treatment is calculated based on the positioning data.

[0212] Furthermore, buffer zones exist regardless of the patient and include characteristics of the drug. These buffer zones can be adjusted by the patient or healthcare professional, with or without preventive modifications, and they can be based on recommendations from healthcare professionals to accept or proceed with therapeutic treatment.

[0213] Advantageously, the target window contains individual I i The positioning data indicates at least one data selected from the group consisting of:

[0214] - the duration of receiving or previously undergoing therapeutic treatment,

[0215] -Personal I i The response of the pharmacotherapy model to the intended therapeutic treatment,

[0216] - the time Tmax before the response of the predetermined therapeutic treatment falls below said minimum threshold of the predetermined target window,

[0217] - The time Tmin such that the response of the predetermined therapeutic treatment does not exceed said maximum threshold of the predetermined target window.

[0218] Advantageously, the positioning data further indicates at least one time interval buffering Tmax before the response of the predetermined therapeutic treatment falls below a minimum buffering threshold of the target window.

[0219] Advantageously, the positioning data further indicates at least one time interval buffer Tmin, such that the response of the predetermined therapeutic treatment does not exceed a maximum buffer threshold of the target window.

[0220] In fact, positioning data indicates that:

[0221] The time of receiving or previously taking therapeutic treatments makes it possible to provide patients with an indication of their receiving or taking therapeutic treatments, which is particularly important for sick, elderly patients or patients with memory disorders. In fact, the indication of the time of receiving or previously taking therapeutic treatments gives an indication of the subsequent receiving or taking of therapeutic treatments.

[0222] For personal use iThe response of the predetermined therapeutic treatment makes it possible to provide the patient with information about their position in the target window. This further allows them to anticipate dangers in the patient's daily events, for example in the case of side effects or increased fatigue. The patient has the opportunity to know where the treatment effect (e.g. the concentration of the active substance in their body) is located in the target window and can rest, perform any activity, without having to worry about the success of their treatment.

[0223] The time Tmax before the response of the predetermined therapeutic treatment falls below a minimum threshold (e.g., a predetermined loss of effectiveness threshold), and the time Tmin before the response of the predetermined therapeutic treatment does not exceed a maximum threshold (e.g., a predetermined toxicity threshold). These two pieces of information also allow patients, individuals, i It is very advantageous to better anticipate life events such as sleep, side effects, work-related travel, and activities outside of the profession.

[0224] Advantageously, the positioning data further indicates at least one time interval buffer Tmax before the effect of the predetermined therapeutic treatment falls below a loss of effectiveness buffer threshold.

[0225] Advantageously, the positioning data further indicates at least one time interval buffer Tmin such that the effect of the predetermined therapeutic treatment does not exceed a toxicity buffer threshold.

[0226] Indeed, providing the patient with a time interval buffer Tmax and / or a time interval buffer Tmin allows the patient to better understand their treatment, assures them of the correct dosage, and allows them greater flexibility and comfort in managing their therapeutic treatment.

[0227] This allows the patient to know how long they have before their treatment response, e.g. the concentration of the active substance of the therapeutic treatment in their body is below the effectiveness loss buffer threshold, within the effectiveness loss buffer region, but also above the critical effectiveness loss region. It is indeed advantageous to be able to inform the patient of the effectiveness loss buffer region, e.g., that they have two hours before entering the critical effectiveness loss region if they do not perform receiving or conducting the therapeutic treatment within this time frame.

[0228] This also allows the patient to know how long they have so that the effect of their treatment (e.g., the concentration of the active substance of their treatment) does not exceed the toxicity buffer threshold in the toxicity buffer zone, but is also below the critical toxicity zone. It is indeed advantageous to inform the patient through the toxicity buffer zone that they must wait (e.g., two hours) to perform receiving or performing treatment in order not to enter the critical toxicity zone if they receive or perform therapeutic treatment within this time frame.

[0229] This is particularly advantageous for patients who wish to adjust their receiving or taking treatment in case of emergencies or daily events. For example, the patient is in the optimal area of ​​the target window, and using the data according to the invention, the patient has the opportunity to take, for example, half a tablet, or take the therapeutic treatment at the ideal time to stay below the critical toxicity threshold, and then the patient knows the remaining time before entering the critical effectiveness loss area. This makes it possible to provide autonomy and comfort to the patient's therapeutic treatment and allows them to anticipate daily events such as work-related travel, any activities, necessary sleep time.

[0230] Additionally, healthcare professionals have the opportunity to adjust the dosage of therapeutic treatments or make treatment decisions.

[0231] In a further embodiment, the method according to the invention further comprises indicating at least one piece of data, preferably via an information device, such as a display device.

[0232] In fact, the indication of at least one piece of data is particularly advantageous, since it makes it possible to provide a detailed description of the data to the patient, the individual, or the like. i Provide clear, precise, and directly accessible and understandable information.

[0233] Furthermore, by accessing clear, precise and understandable information representing their position in the target window, patients can therefore optimize their receipt or conduct of therapeutic treatments, for example, to reduce the side effects of difficult treatments. In fact, instead of taking a complete treatment (e.g., a whole tablet) every 8 hours, a patient may choose to take half of a treatment (e.g., half a tablet) every 4 hours.

[0234] Advantageously, the method according to the invention further comprises, in the event that at each moment t now or in the future the therapeutic effect is below a loss of effectiveness threshold, above a toxicity threshold, below a loss of effectiveness buffer threshold, above a toxicity buffer threshold, an alarm signal is sent, preferably visually or audibly, via the first device and / or via the electronic monitoring device and / or via the display device.

[0235] In fact, according to the invention, it is particularly advantageous to be able to provide the patient with a warning signal at each instant t now or in the future when the treatment effect of the therapeutic treatment exceeds one of the mentioned threshold values.

[0236] Advantageously, the method according to the present invention further comprises: i The projection data model and the indicative data associated with receiving or performing the therapeutic treatment calculate the individual I i Corrected data model.

[0237] Further embodiments of the second method according to the invention are indicated in the dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0238] The present invention will now be described in more detail with reference to the accompanying drawings.

[0239] Figure 1

[0046] Represents a system intended to assist in receiving or performing therapeutic treatment in accordance with the present invention.

[0240] Figure 2 Representation of the theoretical projected pharmacokinetic model for a "robot" individual.

[0241] Figure 3 Represents a pharmacokinetic model that is corrected for an individual taking into account history of receiving or taking therapy.

[0242] Figure 4 Represents a personalized pharmacokinetic model for an individual adapted to "weekend" type events.

[0243] Figure 5A and Figure 5B Represents a personalized pharmacokinetic model for an individual adapted to events of the "high variability" type.

[0244] Fig. 6A , Figure 6B and Figure 6C represents a personalized pharmacokinetic model for an individual, which includes a time interval Tmin and a buffer Tmin for the next dose and a time interval Tmax and a buffer Tmax before the next dose.

[0245] Fig. 7A and Figure 7B Representation of the theoretical projected pharmacokinetic model for a "robot" individual.

[0246] Fig. 8A and Figure 8B Represents a corrected projected pharmacokinetic model for an individual taking into account receiving or undergoing therapy.

[0247] 9A to 9E An example of a time meter representing location data representing an individual receiving or undergoing therapeutic treatment within a target window. DETAILED DESCRIPTION

[0248] Figure 1 A system 1 according to the invention is shown.

[0249] The system 1 according to the invention comprises a first device 2 , a database 3 , an electronic monitoring device 4 and a display device 5 .

[0250] The first device 2 preferably includes a power supply, a processor, a communication unit and a memory. Figure 2The operation is described through FIG. 9 .

[0251] The power source is for example a battery or a battery cell and is arranged to power circuits connecting different elements of the first device 2 .

[0252] The communication unit of the first device 2 is arranged to communicate with a communication unit of a database 3 , a communication unit of an electronic monitoring device 4 and a communication unit of a display device 5 of the system 1 according to the invention.

[0253] The processor of the first device 2 is connected to a power supply, a communication unit and a memory. The processor is arranged to communicate with the communication unit of the first device 2, 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 send a signal to the memory of the first device 2, more specifically to record the calculated data model.

[0254] The database 3 of the system 1 according to the invention comprises a communication unit, which is arranged to communicate with the communication unit of the first device 2. In addition, the database 3 comprises a data model of a therapeutic treatment (also referred to as abbreviation: therapeutic treatment data). The data model of a therapeutic treatment may be a pharmacokinetic and / or pharmacodynamic model for at least one predetermined indication. The pharmacokinetic and / or pharmacodynamic model may include a series of pharmacokinetic and / or pharmacodynamic models for at least one predetermined indication. The data model of a therapeutic treatment may be a function f1(t) of time, as a result of which the concentration of a substance is given, the concentration of a substance in the body after receiving or performing the therapeutic treatment (e.g., a pharmacokinetic model), or a function f1(t) of time, as a result of which the effect in or on the body is given after receiving or performing the therapeutic treatment (e.g., a pharmacokinetic model). In addition to time, the data model of a therapeutic treatment may have one or more additional parameters, such as personal I i Parameters (or personal I i The data model for a therapeutic treatment may include an analytical model (with parameters of such a function) or a data model (with a series of data that varies over time). The data model for a therapeutic treatment may include a continuous function with pharmacokinetics or pharmacokinetic progression that varies over time. However, the data model for a therapeutic treatment may also be simplified, for example using a binary function f1(t) that defines a first time period after receiving or performing the therapeutic treatment, indicating that the treatment is effective or active and defines a second time period after the first time period, indicating that the treatment is no longer effective or active.

[0255] The data model of the therapeutic treatment can also be composed of a series of measurement values ​​M as explained in detail below iDetermine the function f1(t,M i The data model of the therapeutic treatment is represented by the function f1(t). The function f1(t) can be configured based on data from the individual measured responses (e.g., concentrations, measures of effect) (individual I i The dose may be an actual or hypothetical dose.

[0256] Preferably, the database 3 comprises a target window for each predetermined therapeutic treatment (e.g., a therapeutic window and / or reaching an effectiveness threshold and / or not exceeding a toxicity threshold and / or a cost / effectiveness window and / or any other target window, which may also vary over time), which target windows are stored, recorded in the database 3 of the system 1 according to the invention. Possibly, the individual I i The parameters are recorded in the database 3, which may be personal I i The medical data of the individual is recorded in the database 3, more specifically i The variable data are recorded in a database 3. The database 3 may be arranged on the first device 2 or elsewhere, for example stored on a server in an online network.

[0257] For example, the database 3 may include one or more databases. The multiple databases may all be in the first device 2 or in other devices elsewhere, or also distributed in the first device 2 and in several other devices elsewhere. The term "elsewhere", this refers to, for example, a server in an online network. In fact, the database 3 may include a first database, which includes therapeutic treatment data and / or a target window for each predetermined therapeutic treatment.

[0258] The database 3 may include a second database including the personal i specific data such as: a) weight, age, sex or genetic or biomarker selected from a group of individuals i Parameters of individual I i medical data of the individual selected from the group consisting of dose, dosimetry, theoretical time of receipt of each scheduled therapeutic treatment; i Variable data.

[0259] The database 3 may include a third database including data on therapeutic treatments, such as a series of pharmacokinetic and / or pharmacokinetic models for at least one predetermined indication, and a target window for each predetermined therapeutic treatment, and a personal I ispecific data such as: a) weight, age, sex or genetic or biomarker selected from a group of individuals i b) including the individual I for the assimilation and / or removal of each scheduled therapeutic treatment i c) personal information on dose, dosimetry, theoretical duration of each scheduled therapeutic treatment i Variable data.

[0260] In the examples described below, all databases are stored in the first device 2, without limiting the invention. In a variant, the databases may be stored elsewhere.

[0261] The first device 2 or the second database obtains the personal I i specific data of an individual selected from a group of weight, age, sex, or genetic or biomarkers i Parameters of Personal I i These parameters are entered into the memory of the first device 2, for example, by a doctor, a pharmacist or the patient himself.

[0262] The processor of the first device 2 recovers these parameters according to the pharmacokinetic and / or pharmacokinetic model and calculates the personal I i The data model.

[0263] The first device 2 obtains specific data of an individual, namely, the individual I i Medical data such as the effects produced, for example, the assimilation and / or removal of each scheduled therapeutic treatment. i These medical data are entered into the memory of the first device 2 by, for example, a doctor, a pharmacist or the patient himself.

[0264] The processor of the first device 2 performs the operation according to the personal I i Medical data and personal information i The data model calculates personal I i A specific data model.

[0265] The first device 2 obtains personal I i The variable data are the dose and theoretical time of each scheduled therapeutic treatment. i These variable data are entered into the memory of the first device 2, for example, by a doctor, a pharmacist or the patient himself.

[0266] The processor of the first device 2 performs the operation according to the personal I i Variable data and individual I i The specific data model calculates the individual I i Projection data model. Calculate personal I i The step of projecting the data model is optional.

[0267] Data models for therapeutic treatments are usually applicable to all individuals or groups of individuals who share certain parameters, whereas individual I i The projection data model is particularly suitable for personal I i When data models for therapeutic treatment cannot be personalized to individuals i When personalization is not required, the present invention allows for the data model of directly continuing the therapeutic treatment. In addition, when personalization is not required, the present invention allows for the data model of directly continuing the therapeutic treatment. i The projection data model of P is preferably a time-varying function f2(t) (projection function f2(t)). The data model of the therapeutic treatment may be a series of time functions f1(t,P) with the at least one undefined parameter of the model P. i The projection data model can be used to i Parameter P i The same function defined is f1(t,Pi)=f2(t). i The projection data model can also be composed by i Body related measurements M i The function f(t,M i The measurements may be measurements of concentrations of substances in blood or other body fluids, X-rays, electrical measurements, etc., to adapt the data model for therapeutic treatment to the individual. i . The projection function f2(t,M i ) can be represented by a series of measured values ​​M i OK. Projection function f2(t,P i ,M i ) can be represented by a series of measured values ​​M i Determine and / or use personal I i Parameter P i definition.

[0268] In any case, the method uses a data model of the therapeutic treatment. In an example, the method according to the invention uses a data model of the therapeutic treatment for the following calculations. In a preferred example, the method calculates the individual I according to the data model of the therapeutic treatment. i The projection data model, and then use the personal I i The following method is to use the individual I i The projection data model is used to describe it, but it is also possible to use a therapeutic treatment data model and then replace the individual I i Projection data model.

[0269] The first device 2 receives the electronic monitoring device 4, the indicative data associated with receiving or performing a therapeutic treatment. The indicative data particularly includes a timestamp of receiving or performing the therapeutic treatment and optionally also includes a dose of the therapeutic treatment received or performed. The timestamp of receiving or performing the therapeutic treatment is the moment when the receiving or performing occurred. The dose, such as actual or assumed, can also be an intensity (e.g., for behavior). The processor of the first device 2 determines, based on the indicative data associated with receiving or performing the therapeutic treatment and based on the individual I i The projection data model (or the therapeutic treatment data model) calculates the individual I i Corrected data model. i The corrected data model is an indicator of receiving or undergoing current or future therapeutic treatment. i The data model of the correction is or includes a function f3(t) of time (corrected function). Preferably, the correction function f3(t) is updated according to each time stamp or acceptance or execution received by the monitoring device 4. The timestamps of acceptance or execution are defined as t1, t2, ..., tj. The last timestamp tj represents the timestamp of the last acceptance or execution (relative to the current moment). The next timestamp tj+1 is the (planned) time for the next acceptance or execution (relative to the current moment). Preferably, the individual I i The corrected function f3(t) and / or the corrected data model are iteratively determined with the timestamps of acceptance or execution received from the monitoring device 4. The iterative approach may also include a recursive approach. Preferably, each timestamp tj of acceptance or execution received from the monitoring device 4 corresponds to another iteration j+1. Preferably, for each iteration j+1, the individual I of the previous iteration j at the time / timestamp tj of the last acceptance or last execution (residual value of iteration j+1) is determined. i The corrected data model and personal I i The projection data model (or therapeutic treatment data model) determines the individual I i Preferably, for each iteration j+1, the function f3 of the correction of the last iteration j based on the time / timestamp tj of the last acceptance or last execution (residual value of iteration j+1) j (tj) and the time projection function f2(t) (or the time function f1(t)) determine the additional correction function f3 j+1 Preferably, for each recursive loop j+1, a further correction function f3 is determined based on the projection function f2(t,xj+1) at time, based on the residual value xj+1 at iteration j+1 at time (or based on the function f1(t,xj+1) at time of the residual value xj+1 at iteration j+1). j+1(t). Preferably, a projection function f2(t, xj+1) of time based on the residual value xj+1 of iteration j+1 (or a function f1(t, xj+1) of time based on the sum of the residual value xj+1 of iteration j+1) is determined based on the sum of the residual value of iteration j+1 and the projection function f2(t) of time (or a function f1(t) of time).

[0270] The indicative data associated with receiving or performing a treatment may also include the last dose Dj received or last performed, and the processor of the first device 2 may calculate the indicative data according to the time of receiving or performing the treatment (preferably the last time tj received or last performed), the dose of the therapeutic treatment received or performed (preferably the last dose Dj received or last performed), and the dose of the therapeutic treatment received or performed according to the individual I i Projected data model (or data model based on therapeutic treatment), calculate individual I i Preferably, for each iteration j+1, based on the iteration j+1, individual I i The projection data model (or treatment data model) and the residual value of the dose Dj determine the individual I i Preferably, for each recursive cycle j+1, based on the residual value of the cycle of iteration j+1 and the projection function f2(t,Dj) of time, an additional correction function f3 is determined j+1 (t), as a function of dose Dj (or a function of time f1(t,Dj) and as a function of dose Dj).

[0271] The course / progress of current or future therapeutic treatments over time between the last received or performed time tj and the next received or next performed time tj+1 can be monitored by the individual I i The corrected data model and / or the corrected function f3 of (or iteration j+1) j+1 (t) to describe.

[0272] The processor of the first device 2 at each moment t now or in the future according to the personal I i The corrected data model and indicative data associated with receiving or performing a predetermined therapeutic treatment calculates the individual I i Personalized data model. i The personalized data model is personal I i Another name for a corrected data model of , which describes the future course / progress of therapeutic treatment and is not distinguished from this below. In the following disclosure, individual I i Personalized data model and personal I i The corrected data models are interchangeable.

[0273] The processor of the first device 2 preferably calculates the time information for the next acceptance or the next performance of the therapeutic treatment. This information may be valid in the future and corresponds to the current time and a piece of information for calculating the next acceptance or the next performance (this is not a simple alarm) time. The information may include a planned time, which may pass until the next acceptance or the next performance of the therapeutic treatment. The information may include the maximum time planned for the next acceptance or the next performance of the therapeutic treatment, the maximum buffer time planned for the next acceptance or the next performance of the therapeutic treatment, the minimum time planned for the next acceptance or the next performance of the therapeutic treatment, the minimum buffer time planned for the next acceptance or the next performance of the therapeutic treatment, or a combination of these times. Each time can be expressed in absolute time (time, date, etc.) or time interval (for keeping the next acceptance, for example, within 6 hours).

[0274] The minimum time is the time that must be reached as a minimum before the next therapeutic treatment is received or performed. The minimum time is lower than the minimum buffer time, maximum buffer time, or maximum time. When the individual I i When the next therapeutic treatment is resumed or re-administered, the therapeutic treatment may have undesirable effects, such as overdose and / or personal I i Entering an unexpected area, or personal I i Entering the toxic territory of therapeutic treatment.

[0275] The minimum buffer time is the time that must be reached before receiving or performing the next therapeutic treatment as a minimum to have the best effect. The minimum buffer time is lower than the maximum buffer time or the maximum time, and is greater than the minimum time. When the individual I i When the next therapeutic treatment is re-accepted or re-performed, the therapeutic treatment has no undesirable effects but is not optimal, and the individual I i Entering the buffered toxicity zone of therapeutic treatment.

[0276] The maximum time is the time before the next therapeutic treatment must be received or performed at the latest. The maximum time is greater than the minimum buffer time, the maximum buffer time or the minimum time. When the maximum time has passed, the individual I i Re-acceptance or re-implementation of the next therapeutic treatment, therapeutic treatment has lost its effect and / or personal I i Entering the area of ​​loss of effectiveness.

[0277] The maximum buffer time is the time after which the next therapeutic treatment can be received or performed to have an uninterrupted effect without toxicity or side effects. The maximum buffer time is less than the maximum time and greater than the minimum time or the minimum buffer time. i When the next therapeutic treatment is resumed or re-administered between the minimum buffer time and the maximum buffer time, the therapeutic treatment is optimal and / or the individual I i In the optimal area (therapeutic window), there is no loss of effectiveness and no side effects, while maintaining continuity of therapeutic treatment. i When the next therapeutic treatment is re-administered or re-performed between the maximum buffer time and the maximum time, the therapeutic treatment begins to lose its effect (acceptably) and / or the individual I i Entering the validity loss buffer area.

[0278] The time information is calculated, preferably using a target window as described below. However, the time information may also be calculated in another way.

[0279] The calculated time information is preferably displayed using the display device 5, for example as 9A to 9D shown.

[0280] Preferably, the processor of the first device 2 receives the target window for the therapeutic treatment and selects the target window for the therapeutic treatment according to the personal I i The corrected model calculates individual I i Positioning data within the target window for the therapeutic treatment.

[0281] The target window preferably includes a first threshold and a second threshold, and has an optimal area between the first threshold and the second threshold. The first threshold is an effectiveness loss threshold, typically a minimum threshold. The effectiveness loss threshold limits the effectiveness loss area. The second threshold is a toxicity threshold, typically a maximum threshold. The toxicity threshold limits the toxicity area. Preferably, the target window preferably includes a first buffer threshold and a second buffer threshold. The first buffer threshold is an effectiveness loss buffer threshold, typically a minimum buffer threshold. The effectiveness loss buffer threshold limits the effectiveness loss buffer area and the optimal area. The second buffer threshold is a toxicity buffer threshold, typically a maximum buffer threshold. The toxicity buffer threshold limits the toxicity buffer area and the optimal area. The target window and / or its thresholds are represented using the same physical (or variable) parameter (e.g., concentration), as well as the data model of the therapeutic treatment, the projection data model of the individual, and / or the individual I i The corrected data model of . Usually, this parameter is not a parameter (or variable) of time. However, for some cases, this may also be directly time.

[0282] The processor of the first device 2 preferably calculates the personal I iThe current value (current value) of the corrected model and the calculation of the personal I based on the current value i The positioning data is positioned in the target window.

[0283] Preferably, the individual I i The positioning data in the target window is converted into personal I i Time location data in the time target window. i The time positioning data in the time target window preferably includes one or more of the following: minimum time, minimum buffer time, maximum buffer time, maximum time. i The corrected model and the second threshold value calculate the minimum time, preferably based on the next time the therapeutic treatment is re-accepted or performed so that the individual I i The minimum time corresponding to the second threshold value is calculated based on the corrected model of the individual I i The corrected model and the second buffer threshold are used to calculate the minimum buffer time, preferably based on the next re-acceptance or next re-administration of therapeutic treatment so that the individual I i The minimum buffer time is calculated based on the time corresponding to the second buffer threshold of the corrected model. i The corrected model and the first threshold value calculate the maximum time, preferably based on the individual I i The corrected model of the calculation corresponds to the first threshold or the time of intersection with the first threshold. Preferably, based on the individual I i The corrected model and the first threshold value are used to calculate the maximum buffer time, preferably based on the individual I i The corrected model calculates a maximum buffer time corresponding to the first buffer threshold or the time at which the first buffer threshold is intersected.

[0284] Individual I in the time target window i The time positioning data is preferably displayed using a display device 5 .

[0285] However, it is also possible not to use personal I i The time-targeted data in the time target window will be individual I i The positioning data in the target window is converted. For example, because the personal I i The corrected model of has corresponded to the time magnitude. In another example, the individual I is displayed in the target window i Positioning, based on personal i The physical magnitude representation of the corrected model.

[0286] The electronic monitoring device 4 is arranged to detect the individual I iPreferably, the electronic monitoring device 4 comprises a communication unit arranged to communicate with the communication unit of the first device 2. Preferably, the electronic monitoring device 4 comprises a communication unit arranged to automatically detect the individual I i In the example, the sensor or electronic monitoring device 4 is arranged to automatically detect the behavior of the individual I i For medications, the electronic monitoring device 4 may be a device that detects when a medication is removed from its packaging or acts as a trigger for a phototherapy device to initiate or administer a therapeutic treatment. However, the electronic monitoring device 4 may non-automatically detect when a person I i For example, the electronic monitoring device 4 may receive input from a user (e.g., an individual) that identifies the individual I i The moment or time of receiving or carrying out therapeutic treatment. The electronic monitoring device 4 may also be an application for a smartphone, a smart clock, smart glasses, a smart watch or a touch screen tablet.

[0287] Preferably, the electronic monitoring device 4 will monitor the individual I i The time of receiving or performing a therapeutic treatment (sometimes referred to as an abbreviation: time of receiving or performing) is communicated in real time to the first device 2. In a simpler case, the device 4 can only send a signal, and the device 2 can include the time of receiving or performing based on the time of the received signal. In this case, the data associated with receiving or performing simply corresponds to the signal. However, preferably, the device 4 sends a signal containing indicative data of the time of receiving or performing to the device 2. In the sense of the present invention, "real time" means that the time data (timestamp) of the last receiving or performing is sent to the first device 2, thereby allowing the prediction of the time or moment when the next receiving or performing therapeutic treatment must occur. Real time means that the time data (timestamp) of the last receiving or performing is sent to the first device 2 before the next receiving or performing therapeutic treatment. The interval of treatment is the average or planned interval (e.g., dosing regimen) between two consecutive receiving or performing therapeutic treatments. Preferably, real time means that the time data (timestamp) of the last reception or the last performance is sent to the first device 2 as a maximum value within 50% of the time of the interval corresponding to the treatment, preferably as a maximum value within 30% of the time of the interval corresponding to the treatment, preferably as a maximum value within 20% of the time of the interval corresponding to the treatment, preferably as a maximum value within 10% of the time of the interval corresponding to the treatment, preferably as a maximum value within 10% of the time of the interval corresponding to the treatment, preferably as a maximum value within 5% of the time of the interval corresponding to the timestamp of the last reception or the last performance.

[0288] Preferably, the electronic monitoring device 4 includes a power supply, a sensor, a processor, a clock and a memory.

[0289] When a person i When receiving or performing therapeutic treatment, the sensor of the electronic monitoring device 4 is automatically activated or deactivated, for example, in the case of a button, the individual I i The action on the sensor is recorded as an event of receiving or performing a therapeutic treatment. The processor of the electronic monitoring device 4 is arranged to process the event of receiving or performing a therapeutic treatment and generate a signal including indicative data associated with receiving or performing a therapeutic treatment. These indicative data include a timestamp, a dose, and a history of receiving or performing a treatment. In fact, the processor of the electronic monitoring device 4 records indicative data associated with receiving or performing a therapeutic treatment in the memory of the electronic monitoring device 4 for a duration of up to three years.

[0290] The display device 5 comprises a communication unit arranged to communicate with the communication unit of the first device 2. Furthermore, the display device 5 comprises a power source and a processor and is configured to provide the personal 1 with a display device 5 having a plurality of display devices 1 and 12; i Provide clear, simple, precise and directly accessible and understandable information.

[0291] In addition to the display device 5, the output device may also be used to send only the data calculated in the first device 2 to another device or an audio device to send an audio signal with the data calculated in the first device 2. The audio device may only be an audio output or a speaker. Preferably, the system 1 includes an information device to inform 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.

[0292] In an embodiment of the system 1 according to the invention, the first device 2, the electronic monitoring device 4 and the display device 5 are integrated in one single housing. This allows a person to integrate the system 1 according to the invention into a unique and single housing.

[0293] In a further embodiment of the system 1 according to the invention, the first device 2 and the display device 5 are integrated in one housing, separate from the electronic monitoring device 4 .

[0294] In a further embodiment of the system 1 according to the invention, the first device 2 is integrated into a first housing and the electronic monitoring device 4 and the display device 5 are integrated into a second housing separate from the first housing.

[0295] In a further embodiment of the system 1 according to the invention, the first device 2 is integrated into a first housing, the electronic monitoring device 4 is integrated into a second housing and the display device 5 is integrated into a third housing separate from each other.

[0296] In a further embodiment of the system 1 according to the invention, the first device 2 and the electronic monitoring device 4 are integrated into the first housing, separate from the display device 5 .

[0297] In a further embodiment of the system 1 according to the invention, the electronic monitoring device 4 is integrated into a first housing and the first device 2 and the display device 5 are integrated into a second housing separate from the first housing.

[0298] Furthermore, the first device 2 , the database 3 , the electronic monitoring device 4 and the display device 5 of the system 1 according to the invention are communicatively connected via wireless communication or may be physically connected for data exchange.

[0299] Figure 2 A theoretical projected pharmacokinetic model for a "robot" individual is shown.

[0300] The projected pharmacokinetic model may include a set of parameters selected from the group consisting of dose, posology, theoretical time to receive each predetermined therapeutic treatment, and the like. i The variable data may also include a physiological panel of genetic markers selected from biomarkers (e.g., weight, age, sex) of the individual I i The projected pharmacokinetic model may also include parameters of the drug dosing model selected from the group consisting of measured effects of treatment, measured concentrations, side effects, estimated half-life, estimated duration of action, cost / benefit ratio, and individual I i of medical data.

[0301] In fact, the first device 2 contains the individual's variable data, the parameters of the model for the individual and the individual's medical data. These data / parameters are recorded in the memory of the first device 2.

[0302] Based on these data / parameters and a series of drug dosing models, in the current pharmacokinetic situation, the first device 2 calculates the shown projected pharmacokinetic model, which consists of one or more equations representing the concentration variation of the active substance over time for an individual, for a given therapeutic treatment of a predetermined indication.

[0303] The projected pharmacokinetic model theoretically represents a perfectly individual, “robotic” individual who systematically receives or administers treatment at the same time every day.

[0304] The concentration of the active substance for an individual increases and decreases identically based on receipt within a target window (eg, a therapeutic window).

[0305] Figure 3 Individuals with a history of receiving or undergoing treatment are considered i Corrected pharmacokinetic model.

[0306] The first device 2 receives indicative data associated with receiving or performing a predetermined therapeutic treatment from the electronic monitoring device 4. The indicative data comprise in particular a timestamp and optionally a dose of the receiving or performing therapeutic treatment.

[0307] The processor of the electronic monitoring device 4 records indicative data associated with receiving or performing therapeutic treatment in the memory of the electronic monitoring device 4 .

[0308] In operation, the processor of the first device 2 sends a request to the communication unit of the first device 2. The request is sent by the communication unit of the first device 2 to the communication device 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 indicative data from the memory of the electronic monitoring device, more specifically, the extracted indicative data includes timestamps, doses, and a history of receiving or performing therapeutic treatments. The processor of the electronic monitoring device 4 sends the extracted indicative data to the communication unit of the electronic monitoring device 4. The indicative data is sent 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 indicative data received by the communication unit of the first device 2 in the memory of the first device 2.

[0309] The processor of the first device 2 determines the indicative data associated with receiving or performing a predetermined therapeutic treatment and the personal I i Projection data model ( Figure 2 ) Calculate individual I i Corrected data model.

[0310] The personal I obtained by the method according to the present invention i The corrected data model represents the data for individual I i The concentration of active substances is corrected over time and includes a target window, such as individual I i The corrected data model takes into account indicative data associated with receiving or conducting a therapeutic treatment and is particularly advantageous in that it allows for the provision of a data model that takes into account differences from conventional pharmacokinetic models and that takes into account deviations from the prescribed treatment.

[0311] In fact, according to the present invention, the individual iThe corrected pharmacokinetic model makes it possible to interpret that when a peak in response is observed in the model (e.g., a peak in the concentration of the active substance of the therapeutic treatment), if it coincides with the event of receiving or taking the therapeutic treatment, it will not be attributed to rapid assimilation, but rather explained as being caused by receiving or taking the treatment. A trough in the therapeutic treatment response in the model (e.g., a trough in concentration), if it coincides with the absence of the event of receiving or taking the therapeutic treatment for a period of time, will be explained by forgetting to receive or take the therapeutic treatment rather than rapid removal.

[0312] Therefore, because the individual corrected data model takes into account indicative data associated with receipt of therapeutic treatment, differences can be explained and changes in effect are not attributed to erroneous causes.

[0313] Figure 4 A personalized pharmacokinetic model for an individual that accommodates a "weekend" type of event is shown.

[0314] The personal I obtained by the method according to the present invention i The personalized pharmacokinetic model represents the i The concentration of active substances over time and including the target window (e.g. for individual I i The personalized pharmacokinetic model takes into account indicative data associated with receiving or conducting treatment.

[0315] The illustrated personalized pharmacokinetic model further comprises a first minimum threshold corresponding to an effectiveness loss threshold, more specifically a minimum critical effectiveness loss threshold, and a first maximum threshold corresponding to a toxicity threshold, more specifically a maximum critical toxicity threshold.

[0316] The illustrated personalized pharmacokinetic model further includes a second minimum threshold corresponding to a loss of effectiveness buffer threshold and a second maximum threshold corresponding to a toxicity buffer threshold.

[0317] Furthermore, the personalized pharmacokinetic model makes it possible to position the concentration of the active substance for an individual within a target window at each moment t now or in the future, e.g., the therapeutic window allows an individual to identify at each moment t now or in the future whether they are close to a first minimum threshold, a first maximum threshold, a second minimum threshold, a second maximum threshold.

[0318] The target window can change over time, particularly if an event is detected and the patient or healthcare provider needs to understand the reason for this behavior and educate the patient for good treatment compliance.

[0319] In fact, the concentrations of active substances were observed to be below the second minimum threshold corresponding to the buffer threshold for loss of effectiveness. In the present case, this can be explained by the fact that these occurred on the weekend and the patients agreed to events such as sleeping and did not receive their treatment at 8:00 AM as they do every day of the week, but at 11:00 AM.

[0320] The target window is dynamic and adjustable, and in anticipation of this "weekend" type event, it is possible for the patient or healthcare provider to adjust the buffer thresholds to limit and educate the patient for better treatment compliance, with the goal of maintaining the concentration of the active substance in the patient's body between the buffer thresholds of the target window.

[0321] Figure 5A and Figure 5B A personalized pharmacokinetic model adapted for an individual to a "high variability" type of event is shown.

[0322] The individualized pharmacokinetic model represents the concentration of the active substance over time for the individual and includes a target window, which itself includes e.g. Figure 4 The threshold mentioned in .

[0323] When a patient or a healthcare provider detects a high variability in the concentration of the active substance for an individual, which results in several times above the toxicity buffer threshold, even above the critical toxicity threshold and below the effectiveness loss buffer threshold, the high variability is interpreted as a failure of treatment compliance, more specifically as an irregular acceptance or administration of treatment, with regard to obtaining indicative data of the acceptance or administration of treatment by the electronic monitoring device 4 .

[0324] In cases where high variability due to treatment adherence is detected, the goal is to allow patients or healthcare providers to create target windows with narrower buffer thresholds to limit patients to receive or perform treatment with better adherence ( Figure 5A ).

[0325] When better treatment adherence is observed by the patient or healthcare provider in response to high variability, this represents the fact that the patient is being managed correctly in terms of receiving good education on treatment adherence behavior. In this case, the target window can be adjusted again by re-increasing the space between the buffer thresholds ( Figure 5B ), with the goal of providing more flexibility and comfort to the now-aware and educated patient with good treatment compliance.

[0326] Fig. 6A , Figure 6B and Figure 6CA personalized pharmacokinetic model for an individual is shown, including the time interval Tmin and buffer Tmin for the next dose and the time interval Tmax and buffer Tmax before the next dose.

[0327] The processor of the first device 2 preferably processes the data according to the personal I at each time t now or in the future. i The personalized data model and the indicative data of receiving or conducting therapeutic treatment are used to calculate the individual I of the predetermined therapeutic treatment. i In the target window, Personal I i The target window further includes a predetermined maximum effectiveness loss threshold and a predetermined toxicity threshold.

[0328] In fact, from the personal i Starting with the personalized data model and indicative data, personal I i The targeting data is personalized and takes into account differences in treatment adherence.

[0329] In practice, based on personal i A personalized data model of known concentration curves, taking into account indicative data of receiving or conducting a therapeutic treatment, can determine at each moment t now or in the future, what will be the concentration curve over time after receiving or conducting the treatment at moment t.

[0330] Tmin( Fig. 6A ) is calculated as the time from the present moment to the moment when receiving or administering a therapeutic treatment will result in a concentration peak at the limit of the toxicity zone. In addition, if the concentration peak remains below the toxicity zone whenever a therapeutic treatment is administered or administered, then Tmin is equal to 0. Just as Tmin calculations are determined based on the time from now to the next time a therapeutic treatment is administered or administered, Tmin can also be calculated for different doses, such as half of the therapeutic treatment administered.

[0331] Buffer Tmin( Figure 6B ) is calculated as the time between the current moment to the moment when receiving or performing therapeutic treatment will result in a concentration peak at the limit of the toxic buffer zone. In addition, if, regardless of the moment of receiving or performing therapeutic treatment, the concentration peak remains below the toxic buffer zone, then the buffer Tmin is equal to 0.

[0332] Having access to the time interval Tmin and the time interval buffer Tmin is particularly advantageous for the patient and / or for the healthcare professional because it makes it possible to anticipate any event, for example the patient knows that they have to plan several hours of travel to receive or undergo treatment, knowing that they will exceed the toxicity buffer threshold but also knowing that they will not exceed the critical toxicity threshold.

[0333] Tmax( Figure 6C ) is calculated as the time between the current moment and the moment when the concentration would drop below the limits of the loss of effectiveness zone if no therapeutic treatment was received or performed within this time interval Tmax.

[0334] Buffer Tmax( Figure 6C ) is calculated as the time between the current moment and the moment when the concentration would drop below the limit of the loss of effectiveness buffer zone if no therapeutic treatment is received or carried out within this time interval buffer Tmax.

[0335] Having access to the time interval Tmax and the time interval buffer Tmax is particularly advantageous for patients and / or healthcare professionals because it makes it possible to anticipate events, for example a patient knows that they must receive or perform a therapeutic treatment (buffer Tmax) within 4 hours, but if they are unable to perform this within 4 hours, they still have, for example, 2 additional hours before entering the critical effectiveness loss area.

[0336] Furthermore, the buffer Tmin / Tmax can be adjusted by the patient or healthcare professional depending on the sensations such as very strongly felt side effects. Furthermore, the buffer area can be adjusted / modified for better adherence to defined habits, in particular habits that can be learned by acquiring history. In fact, the buffer area Tmin / Tmax can be dynamically recalculated based on the acceptance history in order to better correspond to the actual behavior (e.g., adaptation to a specific behavior that only occurs on weekends, such as sleeping).

[0337] It is also important to get patients into the habit of receiving or doing treatment, and to do this, a dynamic buffer zone is necessary. The goal is to start a narrow optimal zone for the patient, that is, with a significant buffer zone for toxicity and a significant buffer zone for loss of effectiveness, with the goal of forcing the patient to develop a habit of receiving or doing regular therapeutic treatment. Once the patient develops a habit of receiving or doing therapeutic treatment, the buffer zones for toxicity and loss of effectiveness are reduced, limited, and the optimal zone becomes larger, providing more comfort and flexibility in managing their therapeutic treatment.

[0338] This can advantageously make patients aware of the importance of regularity in their therapeutic treatment, i.e. having optimal treatment compliance in order to remain in the optimal area of ​​the therapeutic effect in the target window. i And this positioning data becomes possible.

[0339] It is important that patients be able to make connections between their treatment regimen (i.e., their therapeutic treatment), the effectiveness of that therapeutic treatment, and treatment adherence data.i The positioning data allows patients, individuals i Adjust their treatment regimen and healthcare providers to personalize the individual I i treatment in order to avoid over-therapeutic treatment that would provide the intended difference.

[0340] The target window's loss-of-effectiveness threshold and toxicity threshold can be adjusted based on an individual's treatment compliance.

[0341] In addition, personal I i The positioned data in the target window indicates at least one data selected from the group:

[0342] - the duration of receiving or previously receiving therapeutic treatment,

[0343] – For personal use i The response of the pharmacotherapy model to the intended therapeutic treatment,

[0344] - the time Tmax before the response of the predetermined therapeutic treatment falls below said minimum threshold of the predetermined target window,

[0345] - The time Tmin such that the response of the predetermined therapeutic treatment does not exceed said maximum threshold of the predetermined target window.

[0346] Fig. 7A and Figure 7B A theoretical projected pharmacokinetic model for a "robot" individual is shown.

[0347] The projected pharmacokinetic model may include a set of parameters selected from the group consisting of dose, posology, theoretical time to receive each predetermined therapeutic treatment, and the like. i The variable data may also include selected from the group consisting of weight, age, gender, genetic markers, biomarkers for individual I i The projected pharmacokinetic model may further include parameters of the drug dosing model selected from the group consisting of measured therapeutic effects, measured concentrations, side effects, estimated half-lives, estimated durations of action, and the like. i of medical data.

[0348] In fact, the first device 2 acquires the individual's variable data, the model parameters for the individual and the individual's medical data. These data / parameters are recorded in the memory of the first device 2.

[0349] Based on these data / parameters and a series of drug dosing models, in the present pharmacokinetic case, the first device 2 calculates the projected pharmacokinetic model shown, which consists of one or more equations representing the effect of the therapeutic treatment over time for a given therapeutic treatment for a predetermined indication. Depending on the method of action of the treatment, the effect of the treatment may vary over time.

[0350] The projected pharmacokinetic model ( Fig. 7A ) further includes a first minimum threshold corresponding to a validity loss threshold, more specifically a minimum critical validity loss threshold and a second minimum threshold corresponding to a validity loss buffer threshold.

[0351] The projected pharmacokinetic model ( Figure 7B ) further includes a first maximum threshold corresponding to a toxicity threshold, more specifically a maximum critical toxicity threshold and a second maximum threshold corresponding to a toxicity buffer threshold.

[0352] The frequency of treatment behaviors is designed to maintain the effect of the treatment within the treatment's window of effectiveness, i.e., between underexposure to the behavior that renders the treatment ineffective (loss of effectiveness threshold) and overexposure to the behavior that renders the treatment ineffective and makes the treatment potentially dangerous (toxicity threshold).

[0353] It is important that the patient sees the effects of the treatment. In fact, for every treatment received or administered, there is an associated effect that can be directly recognized by the patient, such as the sensation of pain, or an effect that cannot be directly recognized, such as the concentration of the active substance of the treatment.

[0354] The effects associated with each receipt or administration of a treatment can be measured and / or identified by concentrations (plasma, saliva, urine, tissue, blood, capillaries, etc.), biomarkers, measurable or calibrated treatment effects (e.g., calibration of pain thresholds).

[0355] Projected pharmacokinetic models are theoretical and represent a perfect individual, a "robot" individual who systematically receives or takes treatment at the same time every day. The effect of treatment for an individual increases and decreases identically based on receiving therapeutic treatment in a target window (eg, a therapeutic window).

[0356] Fig. 8A and Figure 8B A corrected projected pharmacokinetic model for an individual taking into account history of receiving or conducting treatments is shown.

[0357] The first device 2 receives indicative data associated with receiving or performing a predetermined therapeutic treatment from the electronic monitoring device 4. The indicative data include, among other things, timestamps, dosages and a history of receiving or performing the therapeutic treatment.

[0358] The processor of the electronic monitoring device 4 records indicative data associated with receiving or performing therapeutic treatment in the memory of the electronic monitoring device 4 .

[0359] In operation, the processor of the first device 2 sends a request to the communication unit of the first device 2. The request is sent 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 indicative data from the memory of the electronic monitoring device, more specifically, the extracted indicative data includes timestamps, dosages, and a history of receiving or performing therapeutic treatments. The processor of the electronic monitoring device 4 sends the extracted indicative data to the communication device of the electronic monitoring device 4. The indicative data is sent 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 indicative data received by the communication unit of the first device 2 in the memory of the first device 2.

[0360] The processor of the first device 2 determines the indicative data associated with receiving or performing a predetermined therapeutic treatment and the personal I i Projected pharmacokinetic data model ( Fig. 7A and Figure 7B ) Calculate individual I i Corrected pharmacokinetic data model ( Fig. 8A and Figure 8B ).

[0361] The personal I obtained by the method according to the present invention i The adjusted pharmacokinetic model represents the effect of the adjusted therapeutic treatment over time and includes a target window.

[0362] Considering the history of receiving or conducting treatment ( Fig. 8A )'s corrected pharmacokinetic model further comprises: a first minimum threshold corresponding to an effectiveness loss threshold, more specifically a minimum critical effectiveness loss threshold, and a second minimum threshold corresponding to an effectiveness loss buffer threshold.

[0363] Considering the history of receiving or undergoing treatment shown ( Figure 8B ) further comprises a first maximum threshold corresponding to a toxicity threshold, more specifically a maximum critical toxicity threshold, and a second maximum threshold corresponding to a toxicity buffer threshold.

[0364] For example, between underexposure that renders the treatment ineffective (loss of effectiveness threshold) and overexposure that renders the treatment potentially dangerous (toxicity threshold), the frequency of treatment actions is intended to maintain the effect of the therapeutic treatment within the treatment's window of effectiveness.

[0365] The corrected pharmacokinetic model takes into account indicative data associated with receiving or administering therapeutic treatment and is particularly advantageous because it enables the provision of a pharmacokinetic model that takes into account differences relative to prescribed treatment relative to conventional models.

[0366] In fact, according to the present invention, the individual i The corrected pharmacokinetic model can be interpreted such that when a peak in response is observed in the model (e.g., a peak in the effect of a therapeutic treatment), it will be interpreted as being due to the receipt or administration of the therapeutic treatment if it coincides with an event of receipt or administration of the therapeutic treatment. A trough in the treatment response in the model (e.g., a trough in the effect of a therapeutic treatment), if it coincides with an event that is not associated with receipt or administration of the therapeutic treatment over a period of time, will be interpreted as being due to forgetting to receive or administer the therapeutic treatment.

[0367] Therefore, because the individual corrected data model takes into account indicative data associated with receipt of therapeutic treatment, differences can be explained and changes in effect are not attributed to erroneous causes.

[0368] Fig. 9A , Fig. 9B , Fig. 9C , Fig.9D as well as Fig.9E An example of a time meter representing location data for an individual to receive or undergo treatment in a target window is shown, where each section represents one hour.

[0369] Fig. 9A A time meter representing an individual receiving or conducting treatment.

[0370] The time meter is filled to 100% with all segments full, the individual is in the upper buffer zone between the maximum threshold and the maximum buffer threshold, and may not retake or perform healing actions at a penalty above the maximum threshold corresponding to the critical toxicity threshold.

[0371] Fig. 9B A time meter representing two hours after the individual's last treatment or action.

[0372] The meter is filled to 77%, the two sections between the maximum threshold and the maximum buffer threshold are empty, and the individual is in the optimal region below the maximum buffer threshold corresponding to the toxicity buffer threshold. The individual may not re-take or re-perform treatment at a penalty exceeding the maximum threshold corresponding to the critical toxicity threshold.

[0373] However, an individual can retake or take a quarter of a treatment, such as a quarter of a pill, without entering the toxic zone, such as in anticipation of daily events.

[0374] Fig. 9C A time meter representing the four hours after an individual last received or administered treatment.

[0375] The meter is filled to 55%, the two sections between the maximum threshold and the maximum buffer threshold are empty, the two sections of the optimal region are empty, and the individual is in the optimal region, below the threshold of full acceptance. The individual can re-accept or re-perform the treated behavior without risk of exceeding the maximum threshold corresponding to the critical toxicity threshold.

[0376] Fig.9D A time meter representing six hours after the last act of treatment or treatment received by an individual.

[0377] The meter is filled to 33%, the two sections between the maximum threshold and the maximum buffer threshold are empty, the four sections of the optimal region are empty, and the individual is in the lower buffer region between the minimum buffer region and the minimum region. The three sections of the effectiveness loss buffer region between the minimum buffer threshold and the minimum threshold are full, and the patient knows that they have three hours of effectiveness of the therapeutic treatment. The individual must retake or re-perform the treatment behavior within the next three hours, but will be penalized for falling below the minimum threshold corresponding to the critical effectiveness loss threshold.

[0378] Fig.9E A time meter representing nine hours after the last act of treatment or treatment received by an individual.

[0379] The meter is filled to 0%, the two sections between the maximum threshold and the maximum buffer threshold are empty, the four sections of the optimal zone and the three sections between the minimum buffer threshold and the minimum threshold are empty. The treatment no longer has any therapeutic effect on the individual. They must absolutely re-accept or re-perform the treated behavior.

[0380] It will be understood that the present invention is not in any way limited to the embodiments described below and that many modifications may be made thereto without departing from the scope of the appended claims.

Claims

1. To assist individuals i Methods of receiving or conducting therapeutic treatment, include: - obtaining a data model of a therapeutic treatment from a database (3) by means of a first device (2), wherein the data model comprises a series of drug dosage models for at least one predetermined indication and a target window for the therapeutic treatment; - Recording of personal information through electronic monitoring devices (4) i Indicative data associated with receiving or undergoing the therapeutic treatment, wherein the indicative data includes personal I i timestamp; - receiving, via the first device (2), information from the electronic monitoring device (4) relating to the individual I i said indicative data associated with receiving or undergoing said therapeutic treatment; - calculating, by the first device (2), the personal I according to the data model of the therapeutic treatment and according to the indicative data associated with receiving or carrying out the therapeutic treatment i Corrected data model; - through the first device (2) according to the personal I i The calibrated model and the target window for individual I to undergo the predetermined therapeutic treatment according to the indicative data received or performed i Calculation of localization data, wherein the localization data takes into account differences in treatment compliance.

2. The method according to claim 1 further comprises obtaining, by the first device (2), the personal I i specific data, include: - Individuals selected from the group for receiving each scheduled therapeutic treatment dose, dosimetry, treatment duration i Variable data, and / or - selected from a physiological panel of biomarkers, genetic markers, for individual I i parameters of said data model of therapeutic treatment, and / or - Individual I selected from the group of measured effect of treatment, measured concentration, side effects, estimated half-life, estimated duration of action, cost / effectiveness ratio i medical data, wherein, by means of the first device (2), according to the data model of the therapeutic treatment and according to the individual I i The variable data of the individual I i wherein the personal I is calculated based on the data model of the therapeutic treatment and based on the indicative data associated with receiving or performing the therapeutic treatment i Corrected data model.

3. The method according to claim 1 or 2, in, The target window has a person I i The positioning data indicates time information for the next receipt or performance of the therapeutic treatment.

4. The method according to claim 1 or 2 further comprises: i The positioning data is used to calculate the maximum time to be observed for the next reception or conduct of the therapeutic treatment and / or the individual I in the target window of the therapeutic treatment. i The positioning data is used to calculate the minimum time to be observed before the next receipt or performance of the therapeutic treatment.

5. The method according to claim 1 or 2 further comprises: i The positioning data is used to calculate the maximum buffer time to be observed in the next receipt or performance of the therapeutic treatment and / or the target window for the treatment of the individual I i The positioning data is used to calculate a minimum buffer time to be observed before the next receipt or performance of the therapeutic treatment.

6. The method according to claim 1 or 2, in, The target window contains individual I i The positioning data indicates at least one data selected from the group consisting of: - the duration of previous therapeutic treatment received, -From for personal I i The response of the pharmacotherapy model to the intended therapeutic treatment, - the maximum time before the response to the scheduled therapeutic treatment falls below the minimum threshold of the target window, - Minimum time such that the response of the intended therapeutic treatment does not exceed the maximum threshold of the target window.

7. The method according to claim 6, in, The positioning data indicates at least one time interval buffer Tmax before the response of the predetermined therapeutic treatment falls below a minimum buffer threshold of a target window; and / or wherein the positioning data indicates at least one time interval buffer Tmin such that the response of the predetermined therapeutic treatment does not exceed a maximum buffer threshold of a target window.

8. The method according to any one of claims 1, 2, and 7, further comprising excluding, by the first device (2), first indicative data associated with acceptance or conduct received from the electronic monitoring device (4) from a set of said indicative data associated with acceptance or conduct.

9. The method according to any one of claims 1, 2, and 7, further comprising indicating at least one piece of data through an information device.

10. The method according to any one of claims 1, 2 and 7, in, The indicative data associated with receiving or administering the predetermined therapeutic treatment includes a timestamp and a dosage, the method comprising: - Recording of personal information through electronic monitoring devices (4) i timestamps and dosages associated with receipt or administration of said therapeutic treatment; - by means of a first device (2) according to said data model of therapeutic treatment and in accordance with the data related to the receiving or performing individual I i The therapeutic treatment is associated with a timestamp and dose calculation for individual I i Corrected data model.

11. The method according to any one of claims 1, 2 and 7, in, Each time stamp received or performed by the electronic monitoring device (4) is iteratively re-determined for the individual I i A corrected data model where, in each iteration, the individual I of the last iteration j at the time of the last acceptance or last execution is i The corrected data model and the treated data model or the individual projection data model determine the individual I i Additional correction data model.

12. The method according to claim 2, in, The physiological group includes one or more of weight, age, and gender.

13. The method according to claim 9, in, The information device comprises a display device (5).

14. Intended to assist individuals i A system (1) for receiving or performing therapeutic treatment, the system (1) include: - a database with data models of therapeutic treatments (3), - For recording and personal i an electronic monitoring device (4) that provides a time stamp associated with receipt or performance of said therapeutic treatment, - a first device (2) for treating the patient according to the data model for therapeutic treatment and for communicating with the patient i The timestamp associated with receiving or undergoing the therapeutic treatment is performed on the individual i The calculation of the corrected data model and the i The corrected model performs the therapeutic treatment within the target window for individual I i calculation of positioning data and / or calculation of time information for the next receipt or performance of said therapeutic treatment, wherein said positioning data takes into account differences in treatment compliance; - an information device that administers said therapeutic treatment to the individual in the target window i positioning data and / or time information for the next receipt or performance of said therapeutic treatment.

15. System (1) according to claim 14, in, The first device (2), the information device and the electronic monitoring device (4) are integrated into a single housing.

16. The system (1) according to claim 14, in, The electronic monitoring device (4) and the information device are integrated into a housing separate from the first device (2).

17. The system (1) according to claim 14, in, The electronic monitoring device (4), the information device and the first device (2) are integrated into a single housing.

18. The system (1) according to claim 14, in, The first device (2), the database (3), the information device and the electronic monitoring device (4) comprise a communication unit and are communicatively connected via wireless communication or can be physically connected for the exchange of data.

19. System (1) according to any one of claims 14 to 18, in, 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 is configured to generate indicative data associated with receiving or performing a predetermined therapeutic treatment, the indicative data comprising a timestamp, a dosage and a history of receiving or performing the therapeutic treatment.

20. A computer program product for storing a computer program, the computer program comprising software code portions for implementing the following steps when the computer program is executed on a processor (2): - obtaining, by means of a processor, a data model of a therapeutic treatment from a database (3); - receiving, via the processor, information from the electronic monitoring device (4) relating to the individual i timestamp associated with receiving or conducting therapeutic treatment, - by a processor according to said data model of therapeutic treatment and the personal I i Indicative data associated with receiving or undergoing the therapeutic treatment is calculated for the individual I i Corrected data model; - by the processor based on personal I i The calibration model is performed on individual I i calculation of positioning data within a target window of a predetermined therapeutic treatment and / or calculation of time information for the next receipt or performance of said therapeutic treatment, in, The localization data takes into account differences in treatment compliance.

21. To assist individuals i Methods of receiving or conducting therapeutic treatment, include: - obtaining a data model of a therapeutic treatment from a database (3) by means of a first device (2), wherein the data model comprises a series of drug dosage models for at least one predetermined indication; - recording, by means of an electronic monitoring device (4), indicative data associated with receiving or carrying out said therapeutic treatment, wherein said indicative data includes personal I i timestamp; - receiving, by means of a first device (2) of an electronic monitoring device (4), said indicative data associated with receiving or carrying out said therapeutic treatment; - calculating, by the first device (2), the personal I according to the data model of the therapeutic treatment and the indicative data associated with receiving or performing the therapeutic treatment i Corrected data model; - calculating and / or indicating, by the first device (2), time information for the next receipt or next performance of said therapeutic treatment.

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