Apparatus and method for providing customized dosage and usage information of drug

Abstract

An apparatus and method for providing customized dosage / administration information for a drug are disclosed, and a method for providing customized dosage / administration information for a drug according to one embodiment of the present invention may include the steps of: obtaining personalized information including personal details and biometric information of a subject to analysis; generating novel function analysis information of the subject to analysis based on the personalized information; and generating guide information for the administration / dosage of a target drug based on the personalized information and the novel function analysis information.

Description

Technology Field

[0001] The present invention relates to an apparatus and method for providing customized dosage / administration information for drugs. For example, the present invention relates to an analytical technique for providing a dosage / administration guide for Colistin for personalized treatment. Background Technology

[0002] Population pharmacokinetic analysis is an analytical technique that quantitatively analyzes how individual pharmacokinetic parameters differ, how they exhibit a distribution, and how individual differences appear random, although there are aspects where they do not. Individual pharmacokinetic parameters differ, some of which are explained by fixed-effects such as height, body weight, and creatinine clearance, and some are due to random variability.

[0003] Therefore, in population pharmacokinetics, interests include not only representative values ​​of pharmacokinetic parameters of the entire population (e.g., mean, median, etc.) but also the degree of dispersion (e.g., variance, standard deviation) and the estimation of individual pharmacokinetic parameters, and techniques for estimating these include the Two-Stage Approach and the Nonlinear Mixed-Effects Modeling Approach.

[0004] Meanwhile, less than 100 years after antibiotics were first developed, the world faced the problem of antibiotic-resistant bacteria, and the World Health Organization has identified antibiotic-resistant bacteria as one of the top 10 global health threats. The emergence and spread of such antibiotic-resistant bacteria are assessed to have a similar impact to that of novel infectious diseases for which there is no cure.

[0005] In this regard, a UK government report predicted that if appropriate measures are not taken, 10 million people worldwide will die annually due to drug-resistant bacteria by around 2050, a figure that exceeds the mortality rate from cancer. In Korea as well, following the enforcement of the Infectious Disease Control and Prevention Act in December 2010, health authorities designated six types of multidrug-resistant bacteria as legal infectious diseases and are applying intensive management through sample surveillance.

[0006] In particular, multidrug-resistant Acinetobacter baumannii (MRAB) showed the most rapid increase in resistance among the six strains, rising from 20% in 2002 to 89% in 2018. Furthermore, according to the results of sample surveillance on six types of antibiotic-resistant bacteria reported by the Korea Centers for Disease Control and Prevention from 2013 to 2017, infections caused by MRAB ranked second after MRSA. In the case of MRAB, not only did the resistance rate increase, but it also accounted for a high proportion of resistant strains isolated in intensive care units, rising from 52.9% in 2006 to 89.8% in 2013.

[0007] Despite the increase in MRAB, there is a shortage of effective treatments, and currently, the leading treatment is Colistin. Colistin is an antibiotic that has not been widely used because its demand has plummeted due to its narrow therapeutic range and the common side effect of nephrotoxicity.

[0008] Meanwhile, despite the increase in multidrug-resistant bacteria, the development of new antimicrobial agents has not kept pace, leading to increased interest in previously underutilized antimicrobial agents (Reviving drugs); among these, colistin is a representative antimicrobial agent that has recently come into the spotlight.

[0009] As such, although colistin is the primary treatment for multidrug-resistant Acinetobacter bacilli (MRAB), it shows a mortality rate of about 50% when used in patients in the intensive care unit and causes nephrotoxicity in about 50% of patients. This is because colistin is an antimicrobial agent with a narrow therapeutic range, and unlike other antimicrobial agents with a broad therapeutic range, it has the characteristic that it may be ineffective when administered at a low dose and toxicity may occur when administered at a high dose, depending on the dosage and administration method.

[0010] As such, for antimicrobial agents with a narrow therapeutic range, a strategy is needed to maximize the efficacy and minimize side effects through therapeutic drug concentration monitoring. The problematic groups for antimicrobial agents with a narrow therapeutic range may be the elderly (toxicity) or obese (low efficacy) groups, and it is necessary to apply individualized colistin dosages and regimens that take these factors into account.

[0011] The technology forming the background of this invention is disclosed in Korean Registered Patent Publication No. 10-1949102. The problem to be solved

[0012] The present invention aims to solve the problems of the aforementioned conventional technology by providing a device and method for providing customized dosage / administration information for drugs that can provide guidance on the appropriate dosage / administration for target drugs using parameters and variables that affect individual pharmacokinetic characteristics.

[0013] However, the technical problems that the embodiments of the present invention aim to solve are not limited to the technical problems described above, and other technical problems may exist. means of solving the problem

[0014] As a technical means for achieving the above-mentioned technical problem, a method for providing customized dosage / administration information for a drug according to one embodiment of the present invention may include the steps of: acquiring personalized information including personal details and biometric information of a subject for analysis; generating novel function analysis information of the subject for analysis based on the personalized information; and generating guide information for the administration / dosage of a target drug based on the personalized information and the novel function analysis information.

[0015] In addition, the above target drug may include colistin.

[0016] In addition, the above biological information may include serum creatinine information and albumin level information of the subject to analysis.

[0017] In addition, the novel function analysis information may include creatinine clearance information of the subject of analysis.

[0018] Additionally, the step of generating the guide information may derive the guide information by utilizing the personal information and the novel function analysis information, including at least one of the loading dose information, maintenance dose information, interval information, and infusion duration information for the target drug, and concentration prediction information including at least one of the peak level and trough level information of the blood concentration of the subject analyzed following the infusion of the target drug.

[0019] In addition, the step of generating the guide information may derive the guide information by inputting the personalized information and the novel function analysis information of the subject to analysis into a pharmacokinetic model that has been constructed using training data including the personalized information, drug administration information, and blood concentration information collected for each of the plurality of subjects.

[0020] In addition, the personal information mentioned above may include the gender, age, and weight information of the subject of analysis.

[0021] In addition, the step of generating the new function analysis information may compute the new function analysis information from the personalized information using weights set using the training data for each of the plurality of items included in the personalized information.

[0022] In addition, a method for providing customized dosage / use information for a drug according to one embodiment of the present invention may include the step of outputting the generated guide information and outputting a time-series blood concentration graph expected when the dosage / use according to the guide information is applied to the subject of analysis.

[0023] In addition, a method for providing customized dosage / use information for a drug according to one embodiment of the present invention may include the steps of receiving a user input that adjusts at least some of the output items included in the output guide information, and outputting a blood concentration graph expected when the dosage / use according to the user input is applied to the subject of analysis.

[0024] Meanwhile, a device for providing customized dosage / administration information for a drug according to one embodiment of the present invention may include a collection unit for acquiring personalized information including personal details and biometric information of a subject for analysis, a personalized analysis unit for generating novel function analysis information of the subject for analysis based on the personalized information, and a guide providing unit for generating guide information on the administration / dosage of a target drug based on the personalized information and the novel function analysis information.

[0025] In addition, the guide providing unit can derive the guide information including at least one of the loading dose information, maintenance dose information, interval information, and infusion duration information for the target drug, and at least one of the peak level and trough level information of the blood concentration of the subject of analysis following the infusion of the target drug, by using the personal information and the novel function analysis information.

[0026] In addition, the guide providing unit can derive the guide information by inputting the personalized information of the subject to analysis and the novel function analysis information into a pharmacokinetic model that has been previously constructed using learning data including the personalized information, drug administration information, and blood concentration information collected for each of the plurality of subjects.

[0027] In addition, the personalization analysis unit can compute the new function analysis information from the personalization information using weights set using the training data for each of the plurality of items included in the personalization information.

[0028] In addition, a device for providing customized dosage / use information for a drug according to one embodiment of the present invention may include an interface unit that outputs the generated guide information and outputs a time-series blood concentration graph expected when the dosage / use according to the guide information is applied to the subject of analysis.

[0029] In addition, the interface unit receives user input that adjusts at least some of the multiple output items included in the output guide information, and can output the blood concentration graph expected when applying the dosage / method according to the user input to the subject of analysis.

[0030] The means for solving the problem described above are merely exemplary and should not be interpreted as intended to limit the present invention. In addition to the exemplary embodiments described above, additional embodiments may exist in the drawings and the detailed description of the invention. Effects of the invention

[0031] According to the means for solving the problem of the present invention described above, it is possible to provide a device and method for providing customized dosage / administration information for a drug that can provide guidance on the appropriate dosage / administration for a target drug by utilizing parameters and variables that affect individual pharmacokinetic characteristics.

[0032] According to the solution to the problem of the present invention described above, when adjusting the dosage / administration of colistin for the treatment of patients with multidrug-resistant Gram-negative bacteria, the effect of colistin can be increased while side effects can be minimized.

[0033] However, the effects obtainable from this invention are not limited to those described above, and other effects may exist. Brief explanation of the drawing

[0034] FIG. 1 is a schematic diagram of a drug dosage / administration guide system according to one embodiment of the present invention. Figure 2 is a conceptual diagram illustrating the therapeutic range of Colistin. Figure 3 is a diagram illustrating an exemplary lookup table for the dosage of Colistin. Figure 4 is a diagram illustrating an interface that inputs personalized user information and outputs new function analysis information based on the personalized information. FIGS. 5a and 5b are conceptual diagrams for illustrating a pharmacokinetic model according to one embodiment of the present invention. Figure 6 is a diagram illustrating an interface that outputs generated guide information. Figure 7 is a diagram illustrating an exemplary time-series blood concentration graph for an analysis subject when a predetermined dose / method of a target drug is applied. FIG. 8 is a schematic diagram of a device for providing customized dosage / use information for drugs according to one embodiment of the present invention. FIG. 9 is a flowchart of an operation for a method of providing customized dosage / use information for a drug according to one embodiment of the present invention. FIG. 10 is a flowchart of the operation for updating a blood concentration graph according to the application of dosage / administration modification based on user input according to one embodiment of the present invention. Specific details for implementing the invention

[0035] Embodiments of the present invention are described below with reference to the attached drawings to enable those skilled in the art to easily implement the invention. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. Furthermore, in order to clearly explain the present invention in the drawings, parts unrelated to the explanation have been omitted, and similar parts throughout the specification are denoted by similar reference numerals.

[0036] Throughout this specification, when a part is described as being "connected" to another part, this includes not only cases where they are "directly connected," but also cases where they are "electrically connected" or "indirectly connected" with other elements interposed between them.

[0037] Throughout the entire specification, when a component is described as being located "on," "on top," "on top," "under," "on bottom," or "on bottom" of another component, this includes not only cases where the component is in contact with the other component but also cases where another component exists between the two components.

[0038] Throughout this specification, when a part is described as "comprising" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but may include additional components.

[0039] The present invention relates to an apparatus and method for providing customized dosage / administration information for drugs. For example, the present invention relates to an analytical technique for providing a dosage / administration guide for Colistin for personalized treatment.

[0040] FIG. 1 is a schematic diagram of a drug dosage / administration guide system according to one embodiment of the present invention.

[0041] Referring to FIG. 1, a drug dosage / administration guide system (10) (hereinafter referred to as the 'dosage / administration guide system (10)') according to one embodiment of the present invention may include a customized drug dosage / administration information providing device (100) (hereinafter referred to as the 'dosage / administration information providing device (100)'), a user terminal (200), an external server (300), and a database (400).

[0042] A capacity / usage information providing device (100), a user terminal (200), an external server (300), and a database (400) can communicate with each other through a network (20). The network (20) refers to a connection structure that enables information exchange between each node, such as terminals and servers. Examples of such a network (20) include, but are not limited to, a 3GPP (3rd Generation Partnership Project) network, an LTE (Long Term Evolution) network, a 5G network, a WIMAX (World Interoperability for Microwave Access) network, the Internet, a LAN (Local Area Network), a Wireless LAN (Wireless Local Area Network), a WAN (Wide Area Network), a PAN (Personal Area Network), a Wi-Fi network, a Bluetooth network, a satellite broadcasting network, an analog broadcasting network, and a DMB (Digital Multimedia Broadcasting) network.

[0043] The user terminal (200) can be any type of wireless communication device, such as a smartphone, smartpad, tablet PC, PCS (Personal Communication System), GSM (Global System for Mobile communication), PDC (Personal Digital Cellular), PHS (Personal Handyphone System), PDA (Personal Digital Assistant), IMT (International Mobile Telecommunication)-2000, CDMA (Code Division Multiple Access)-2000, W-CDMA (W-Code Division Multiple Access), Wibro (Wireless Broadband Internet) terminal.

[0044] In addition, in the description of the embodiments of the present invention, the external server (300) may be a device or server that collects and stores personalized information for each user to transmit personalized information, including personal details of the subject of analysis, biometric information, etc., to the dosage / method providing device (100) disclosed in the present invention. For example, the external server (300) may be linked to various medical / hospital databases, such as a Clinical Data Warehouse (CDW), Healthcare Information System (HIS), Knowledge Management System (KMS), Decision Support System, Electronic Medical Record (EMR), Hospital Customer Relational Management (H-CRM), Order Communication System (OCS), and Picture Archiving and Communication System (PACS).

[0045] Additionally, in the description of the embodiments of the present invention, the database (400) may be a device or server for storing training data for constructing a pharmacokinetic model (specifically, personalized information collected for each of a plurality of subjects, drug administration information, blood concentration information, etc.) and parameters, weights, etc. of the pharmacokinetic model, which is possessed by the dosage / administration providing device (100) disclosed herein.

[0046] In addition, the dosage / administration method providing device (100) disclosed herein may operate to acquire personalized information of an analysis subject, generate novel function analysis information through analysis of the personalized information, and generate guide information for the administration / dosage of a target drug by considering the novel function analysis information.

[0047] Meanwhile, in the description of the embodiments of the present invention, the 'target drug' may include Colistin, which is a therapeutic agent (antibiotic) for multidrug-resistant bacteria, but is not limited thereto. It may be determined according to the embodiments of the present invention to be various types of drugs that, as described below, have a relatively narrow therapeutic window and require the establishment of a detailed dosage / administration strategy to maximize the drug's effect while minimizing side effects through monitoring the concentration of the therapeutic drug. As another example, the target drug may include antibiotics such as Vancomycin.

[0048] Figure 2 is a conceptual diagram illustrating the therapeutic range of Colistin.

[0049] Referring to Fig. 2, although Colistin is the primary treatment for multidrug-resistant Acinetobacter bacilli (MRAB), its use in intensive care unit patients results in a mortality rate of approximately 50% and nephrotoxicity in about 50% of patients. This is because Colistin is an antimicrobial agent with a relatively narrow therapeutic window, as illustrated in the graph on the left side of Fig. 2. Consequently, unlike other antimicrobial agents with a relatively wide therapeutic window as illustrated in the graph on the right side of Fig. 2, Colistin may show low efficacy when administered at low doses or toxicity when administered at high doses, depending on the dosage and administration method. For antimicrobial agents with such a narrow therapeutic window (target drugs at our hospital), a strategy is required to maximize efficacy and minimize side effects through therapeutic drug concentration monitoring.

[0050] Figure 3 is a diagram illustrating an exemplary lookup table for the dosage of Colistin.

[0051] Referring to Figure 3, the dosage / administration method currently applied to Colistin is presented in the form of recommendations based on expert consensus. However, these recommendations are not determined by measuring and confirming the actual drug concentration measured in the subject's body when a specific dosage / administration method is applied to the drug, but rather by deriving expert consensus through calculations that simply consider the characteristics of the existing drug and determining recommendations accordingly.

[0052] In this regard, changes in human drug concentration can be expressed through a pharmacokinetic model composed of a model structure and model parameters according to the model structure, and simulations can be performed by assuming various situations using this. In order to construct such a model, the dosage / administration information providing device (100) disclosed herein constructs the pharmacokinetic model by searching for parameters that best explain the learning data using learning data that includes concentration data measured through actual blood samples and the degree of drug administration (Dosing information).

[0053] Below, the specific functions and operations of the dosage / use information providing device (100) will be described.

[0054] The dosage / use information providing device (100) can obtain personalized information including personal details and biometric information of the subject of analysis. For example, the dosage / use information providing device (100) may obtain personalized information by inputting each item of the subject of analysis's personalized information using an input interface displayed through a user terminal (200). As another example, the dosage / use information providing device (100) may receive at least some of the subject of analysis's personalized information from an external server (300) and use it for analysis.

[0055] Figure 4 is a diagram illustrating an interface that inputs personalized user information and outputs new function analysis information based on the personalized information.

[0056] Referring to FIG. 4, the dosage / administration information providing device (100) can collect biological information including serum creatinine information and albumin level information of the subject to analysis, and collect personal information including gender information, age information and weight information of the subject to analysis.

[0057] Specifically, referring to FIG. 4, the interface for inputting personalized information may individually implement an item (A-1) for entering the identifier information (Patient ID) of the subject of analysis, an item (A-2) for entering the personal information of the selected subject of analysis, and an item (A-3) for entering the biometric information of the subject of analysis. For example, the gender of the subject of analysis may be entered through user input selecting male or female, and age, weight, serum creatinine information, and albumin level information may be entered through user input entering specific numerical values, and the unit for each numerical input item may be determined differently depending on the type of personalized information.

[0058] Additionally, the dosage / administration information providing device (100) can generate novel function analysis information of the subject of analysis based on the acquired personalized information. Specifically, referring to Fig. 4B, the dosage / administration information providing device (100) can derive novel function analysis information including creatinine clearance information of the subject of analysis.

[0059] In this regard, according to one embodiment of the present invention, a dosage / administration information providing device (100) can calculate novel function analysis information from personalized information using weights set using learning data including personalized information, drug administration information, and blood concentration information collected for each of a plurality of subjects for each of a plurality of items included in the personalized information.

[0060] Specifically, according to one embodiment of the present invention, the dosage / administration information providing device (100) can calculate creatinine clearance information corresponding to the kidney function analysis information of the subject to analysis through the following Equation 1 (Cockroff-Gault equation).

[0061] [Equation 1]

[0062]

[0063] Here, CrCl is Creatinine Clearance, age is the age of the subject being analyzed, IBW is the weight of the subject being analyzed (wherein it is Ideal Body Weight), and SCr is the Serum Creatinine information of the subject being analyzed. Meanwhile, if the subject is female, the weight of '0.85' in Equation 1 above is multiplied, whereas if the subject is male, the weight of 1 is multiplied instead of 0.85.

[0064] In addition, the dosage / administration information providing device (100) can generate guide information on the administration / dosage of a target drug based on the personal information of the subject of analysis and the novel function analysis information.

[0065] In this regard, the dosage / administration information providing device (100) can derive guide information including at least one of loading dose information, maintenance dose information, interval information, and infusion duration information for a target drug, and at least one of concentration prediction information including peak level and trough level information of the blood concentration of the subject analyzed following the infusion of the target drug, by using personalized information and novel function analysis information.

[0066] FIGS. 5a and 5b are conceptual diagrams for explaining a pharmacokinetic model according to one embodiment of the present invention. Specifically, FIG. 5a shows the architecture of the pharmacokinetic model, and FIG. 5b shows the differential equations and parameter-specific covariate weights applied to the pharmacokinetic model.

[0067] Referring to FIGS. 5a and 5b, the dosage / administration information providing device (100) can derive guide information by inputting the personal information of the subject to analysis and the novel function analysis information into a pharmacokinetic model (1) that has been established using learning data including personal information, drug administration information, and blood concentration information collected for each of a plurality of subjects.

[0068] Meanwhile, referring to Fig. 5b, the key parameters used in the differential equation of the pharmacokinetic model are, for example, the clearance (L / hr) and volume of distribution (L) of Colistin and Colistin Sodium Methanesulfonate (CMS), respectively, and the values ​​of these parameters may be estimated using collected training data.

[0069] In particular, in population pharmacokinetic models, the distribution of pharmacokinetic parameters is assumed to be normal, which allows for the calculation of pharmacokinetic parameter values ​​for individual patients based on the estimated distribution, in addition to the population pharmacokinetic parameters. By examining the correlation between these individual pharmacokinetic parameters and various physiologically explained personalized information of the individual patient (e.g., albumin levels, body weight, etc.), if a correlation exists, the population parameters can be expressed using these covariates.

[0070] Accordingly, the information collected by the dosage / administration information providing device (100) is information that can be seen as having a significant correlation with pharmacokinetic parameters in the pharmacokinetic model process, and using this, pharmacokinetic parameters for a patient with individual information can be calculated, and using this, a simulation using the differential equation of FIG. 5b can be performed to output guide information on the dosage / administration of the target drug as described below.

[0071] Figure 6 is a diagram illustrating an interface that outputs generated guide information.

[0072] Referring to FIG. 6, the dosage / administration information providing device (100) can output guide information generated through it. Specifically, the dosage / administration information providing device (100) can implement within the interface an area (C-1) displaying loading dose information and maintenance dose information for a target drug, an area (C-2) displaying interval information and infusion duration information for a target drug, and an area (C-3) displaying concentration prediction information including peak level and trough level information of the blood concentration of the subject of analysis following the infusion of the target drug.

[0073] Additionally, according to one embodiment of the present invention, the dosage / use information providing device (100) may provide a region (C-4) for receiving user input for selecting a simulation pattern to derive guide information for an analysis subject.

[0074] Additionally, the dosage / use information providing device (100) can receive user input that adjusts at least some of the multiple output items included in the output guide information.

[0075] For example, the dosage / administration information providing device (100) can primarily output each dosage / administration item calculated using the personal information of the subject of analysis and the novel function analysis information through the pharmacokinetic model described above, and receive user input to adjust the numerical value, level, etc. of each dosage / administration item through a user terminal (200), and additionally simulate the predicted internal changes (e.g., changes in the concentration of the target drug, etc.) for the subject of analysis when the dosage / administration according to the acquired user input is applied.

[0076] This not only provides guidance on the optimal dosage and administration method that reflects the patient's renal function and pharmacokinetic characteristics, but also enables fine-tuning of each item of the dosage and administration method according to the target concentration or preferred method of use by users, such as medical staff.

[0077] Additionally, referring to FIG. 6, the dosage / use information providing device (100) can apply different input methods for user input to adjust the numerical value, level, etc. of individual items according to the data type of each item of guide information.

[0078] For example, referring to FIG. 6, a gauge-type user input method is applied to allow the user to easily set specific numerical values ​​within a predetermined numerical range for the loading dose, maintenance dose, and infusion duration, and a checkbox-type user input method is applied to allow the user to select a specific infusion interval from a plurality of pre-set candidate infusion intervals (e.g., 6-hour, 8-hour, 12-hour, 24-hour intervals, etc.). Additionally, a user input method in the form of an input window is applied to allow the user to directly enter specific numerical values ​​(in mg / L units) for the peak level and trough level of blood concentration, but this is not limited thereto.

[0079] Figure 7 is a diagram illustrating an exemplary time-series blood concentration graph for an analysis subject when a predetermined dose / method of a target drug is applied.

[0080] Referring to FIG. 7, the dosage / administration information providing device (100) can output a time-series blood concentration graph expected when the dosage / administration according to the guide information is applied to the subject of analysis.

[0081] Specifically, the blood concentration graph (D-1 in FIG. 7) is exemplarily a graph where the horizontal axis represents time and the vertical axis represents the blood target drug concentration (ng / ml) of the subject being analyzed, and a reference line (d2) representing the peak level of the blood concentration calculated as guide information or set as a target value according to user input, and a reference line (d1) representing the trough level may be superimposed on the graph.

[0082] Additionally, referring to D-2 of FIG. 7, the dosage / administration information providing device (100) can output various statistical numerical information linked to the blood concentration graph, such as the maximum plasma concentration (Cmax), area under the curve (AUC), time to attainment of the maximum concentration (Tmax), Half-Life Lambda z (LAMZHL), AUC to Last Non-zero Conc (AUCLST), and AUC Infinity Obs (AUCIFO), together with the blood concentration graph.

[0083] In addition, according to one embodiment of the present invention, when a user input is received that adjusts at least some of the output items included in the output guide information, the dosage / use information providing device (100) can update and output a blood concentration graph expected when applying the dosage / use according to the received user input.

[0084] FIG. 8 is a schematic diagram of a device for providing customized dosage / use information for drugs according to one embodiment of the present invention.

[0085] Referring to FIG. 8, the dosage / use information providing device (100) may include a collection unit (110), a personalized analysis unit (120), a guide providing unit (130), and an interface unit (140).

[0086] The collection unit (110) can obtain personalized information including personal details and biometric information of the subject of analysis.

[0087] Specifically, the collection unit (110) can collect biological information including serum creatinine information and albumin level information of the subject to analysis, and collect personal information including gender information, age information and weight information of the subject to analysis.

[0088] The personalized analysis unit (120) can generate novel function analysis information of the subject of analysis based on the acquired personalized information. Specifically, the personalized analysis unit (120) can derive novel function analysis information including creatinine clearance information of the subject of analysis.

[0089] In this regard, according to one embodiment of the present invention, the personalization analysis unit (120) can calculate novel function analysis information from the personalization information using weights set using learning data including the personalization information, drug administration information, and blood concentration information collected for each of the plurality of subjects for each of the plurality of items included in the personalization information.

[0090] The guide providing unit (130) can generate guide information on the dosage / administration of the target drug based on the personal information of the subject of analysis and the new function analysis information.

[0091] In this regard, the guide providing unit (130) can derive guide information including at least one of loading dose information, maintenance dose information, interval information, and infusion duration information for a target drug, and at least one of concentration prediction information including peak level and trough level information of the blood concentration of the subject analyzed following the infusion of the target drug, by using personalized information and novel function analysis information.

[0092] More specifically, according to one embodiment of the present invention, the guide providing unit (130) can derive guide information by inputting the personal information of the subject to analysis and the novel function analysis information into a pharmacokinetic model (1) that has been established using learning data including personal information, drug administration information, and blood concentration information collected for each of a plurality of subjects.

[0093] The interface unit (140) can output guide information generated through it. Additionally, the interface unit (140) can output a time-series blood concentration graph expected when the dosage / method according to the guide information is applied to the subject of analysis.

[0094] Additionally, the interface unit (140) receives user input that adjusts at least some of the multiple output items included in the output guide information, and can update and output a blood concentration graph that is expected when applying the dosage / method according to the received user input.

[0095] Below, based on the details described above, we will briefly examine the operation flow of the present invention.

[0096] FIG. 9 is a flowchart of an operation for a method of providing customized dosage / use information for a drug according to one embodiment of the present invention.

[0097] The method for providing customized dosage / use information for a drug illustrated in FIG. 9 can be performed by the dosage / use information providing device (100) described above. Therefore, even if the content is omitted below, the description of the dosage / use information providing device (100) can be equally applied to the description of the method for providing customized dosage / use information for a drug.

[0098] Referring to FIG. 9, in step S11, the collection unit (110) can obtain personalized information including personal information and biometric information of the subject of analysis.

[0099] Specifically, in step S11, the collection unit (110) can collect biological information including serum creatinine information and albumin level information of the subject to analysis.

[0100] Additionally, in step S11, the collection unit (110) can collect personal information including gender information, age information, and weight information of the subject to analysis.

[0101] Next, in step S12, the personalization analysis unit (120) can generate new function analysis information of the subject of analysis based on the acquired personalization information.

[0102] Specifically, in step S12, the personalized analysis unit (120) can derive novel function analysis information including creatinine clearance information of the subject of analysis.

[0103] In this regard, according to one embodiment of the present invention, in step S12, the personalization analysis unit (120) can calculate novel function analysis information from the personalization information using weights set using learning data including the personalization information, drug administration information, and blood concentration information collected for each of the plurality of subjects, for each of the plurality of items included in the personalization information.

[0104] Next, in step S13, the guide providing unit (130) can generate guide information on the dosage / administration of the target drug based on the personalized information collected through step S11 and the novel function analysis information generated through step S12.

[0105] Specifically, in step S13, the guide providing unit (130) can derive guide information including at least one of loading dose information, maintenance dose information, interval information, and infusion duration information for a target drug, and at least one of concentration prediction information including peak level and trough level information of the blood concentration of the subject analyzed following the infusion of the target drug, by using personalized information and novel function analysis information.

[0106] In this regard, according to one embodiment of the present invention, in step S13, the guide providing unit (130) can derive guide information by inputting the personal information of the subject to analysis and the novel function analysis information into a pharmacokinetic model (1) that has been established using learning data including personal information, drug administration information, and blood concentration information collected for each of the plurality of subjects.

[0107] Next, in step S14, the interface unit (140) can output the guide information generated through step S13.

[0108] In the description above, steps S11 through S14 may be further divided into additional steps or combined into fewer steps according to an embodiment of the present invention. Additionally, some steps may be omitted as necessary, and the order of the steps may be changed.

[0109] FIG. 10 is a flowchart of the operation for updating a blood concentration graph according to the application of dosage / administration modification based on user input according to one embodiment of the present invention.

[0110] The process of updating the blood concentration graph according to the application of dosage / administration modification based on user input illustrated in FIG. 10 can be performed by the dosage / administration providing device (100) described above. Therefore, even if the content is omitted below, the description of the dosage / administration providing device (100) can be applied equally to the description of FIG. 10.

[0111] Referring to FIG. 10, in step S21, the interface unit (140) can output a time-series blood concentration graph expected when applying the dosage / method according to the guide information to the subject of analysis.

[0112] Next, in step S22, the interface unit (140) can receive user input that adjusts at least some of the multiple output items included in the output guide information.

[0113] Next, in step S23, the interface unit (140) can update and output a blood concentration graph expected when applying the dosage / method based on the user input obtained in step S22 to the subject of analysis.

[0114] In the description above, steps S21 to S23 may be further divided into additional steps or combined into fewer steps according to an embodiment of the present invention. Additionally, some steps may be omitted as necessary, and the order of the steps may be changed.

[0115] A method for providing customized dosage / administration information for a drug according to one embodiment of the present invention may be implemented in the form of program instructions that can be executed through various computer means and recorded on a computer-readable medium. The computer-readable medium may include program instructions, data files, data structures, etc., either individually or in combination. The program instructions recorded on the medium may be those specifically designed and configured for the present invention, or they may be those known and available to those skilled in the art of computer software. Examples of computer-readable recording media include magnetic media such as hard disks, floppy disks, and magnetic tapes; optical recording media such as CD-ROMs and DVDs; magneto-optical media such as floptical disks; and hardware devices specifically configured to store and execute program instructions, such as ROM, RAM, and flash memory. Examples of program instructions include machine code, such as that generated by a compiler, as well as high-level language code that can be executed by a computer using an interpreter, etc. The above-described hardware device may be configured to operate as one or more software modules to perform the operation of the present invention, and vice versa.

[0116] In addition, the method for providing customized dosage / use information for the aforementioned drug may also be implemented in the form of a computer program or application executed by a computer stored on a recording medium.

[0117] The foregoing description of the present invention is for illustrative purposes only, and those skilled in the art will understand that other specific forms can be easily modified without altering the technical concept or essential features of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single unit may be implemented in a distributed manner, and components described as distributed may likewise be implemented in a combined form.

[0118] The scope of the present invention is defined by the claims set forth below rather than by the detailed description above, and all modifications or variations derived from the meaning and scope of the claims and the concept of equivalents thereof should be interpreted as being included within the scope of the present invention. Explanation of the symbols

[0119] 10: Drug Dosage / Administration Guide System 100: Device providing customized drug dosage / administration information 110: Collection Department 120: Personalized Analytics Department 130: Guide Provider 140: Interface section 200: User terminal 300: External Server 400: Database 20: Network 1: Pharmacokinetic Model

Claims

Claim 1 A method for providing customized dosage / administration information for a drug, comprising: a step of obtaining personalized information including personal details and biological information of a subject to analysis; a step of generating novel function analysis information of the subject to analysis based on the personalized information; a step of generating guide information for the administration / dosage of a target drug based on the personalized information and the novel function analysis information; and a step of outputting the generated guide information and outputting a time-series blood concentration graph expected when the dosage / administration according to the guide information is applied to the subject to analysis. Claim 2 A method according to claim 1, wherein the target drug comprises colistin. Claim 3 A method according to paragraph 2, wherein the biological information includes serum creatinine information and albumin level information of the subject to analysis, and the renal function analysis information includes creatinine clearance information of the subject to analysis. Claim 4 A method according to claim 2, wherein the step of generating the guide information comprises deriving the guide information by utilizing the personal information and the novel function analysis information, the guide information including dosage information including at least one of loading dose information, maintenance dose information, interval information, and infusion duration information for the target drug, and concentration prediction information including at least one of peak level and trough level information of the blood concentration of the subject of analysis following the infusion of the target drug. Claim 5 In claim 4, the step of generating the guide information is a method of deriving the guide information by inputting the personal information of the subject to analysis and the novel function analysis information into a pharmacokinetic model that has been previously constructed using learning data including the personal information, drug administration information, and blood concentration information collected for each of the plurality of subjects. Claim 6 In claim 5, the personal information includes gender information, age information, and weight information of the subject of analysis, and the step of generating the novel function analysis information is to compute the novel function analysis information from the personal information using weights set using the learning data for each of the plurality of items included in the personal information. Claim 7 delete Claim 8 A method according to claim 1, further comprising: receiving user input that adjusts at least some of the plurality of output items included in the output guide information; and outputting the blood concentration graph expected when applying the dosage / method according to the user input to the subject of analysis. Claim 9 A device for providing customized dosage / administration information for a drug, comprising: a collection unit for acquiring personalized information including personal details and biometric information of a subject to analysis; a personalization analysis unit for generating novel function analysis information of the subject to analysis based on the personalized information; a guide providing unit for generating guide information on the administration / dosage of a target drug based on the personalized information and the novel function analysis information; and an interface unit for outputting the generated guide information and outputting a time-series blood concentration graph expected when the dosage / administration according to the guide information is applied to the subject to analysis. Claim 10 A device according to claim 9, wherein the target drug comprises colistin, the biological information comprises serum creatinine information and albumin level information of the subject to analysis, and the renal function analysis information comprises creatinine clearance information of the subject to analysis. Claim 11 An apparatus according to claim 10, wherein the guide providing unit derives the guide information by utilizing the personal information and the novel function analysis information, the guide information including at least one of the loading dose information, maintenance dose information, interval information, and infusion duration information for the target drug, and at least one of the peak level and trough level information of the blood concentration of the subject of analysis following the infusion of the target drug. Claim 12 In claim 11, the guide providing unit derives the guide information by inputting the personal information of the subject to analysis and the novel function analysis information into a pharmacokinetic model that has been previously constructed using learning data including the personal information, drug administration information, and blood concentration information collected for each of the plurality of subjects. Claim 13 A device according to claim 12, wherein the personal information includes gender information, age information, and weight information of the subject of analysis, and the personal analysis unit calculates the novel function analysis information from the personal information using weights set using the learning data for each of the plurality of items included in the personal information. Claim 14 delete Claim 15 A device according to claim 9, wherein the interface unit receives user input that adjusts at least some of the plurality of output items included in the output guide information, and outputs the blood concentration graph expected when applying the dosage / method according to the user input to the subject of analysis.

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