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Simplified analysis method and system for pharmacokinetic parameters

A technology of pharmacokinetics and analysis methods, applied in the field of simplified analysis methods and systems of pharmacokinetic parameters, which can solve the problems of expensive WinNonlin and high cost of experimental analysis

Active Publication Date: 2021-01-22
昭衍(北京)医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0010] 3. WinNonlin is expensive, and the cost of experimental analysis is high

Method used

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  • Simplified analysis method and system for pharmacokinetic parameters
  • Simplified analysis method and system for pharmacokinetic parameters
  • Simplified analysis method and system for pharmacokinetic parameters

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0188] Refer to attached Figure 1-5 , according to a specific embodiment of the present invention, the simplified analysis method of pharmacokinetic parameters provided by the present invention is described in detail.

[0189] The invention provides a simplified analysis method for pharmacokinetic parameters, comprising the following steps:

[0190] S100: Import the original data set, create the result data set, and perform the first data format conversion on the characters in the variable value that the program needs to call, and convert it into a digital format;

[0191] Step S100 specifically includes the following steps:

[0192] S101: importing the original data set, extracting all the information in the original data set to create a result data set;

[0193] S102: extract and rename variables required for operation in the result data set;

[0194] S103: Convert the fourth character in the variable extracted from the result data set to the first character "." of the m...

Embodiment 2

[0265] According to a specific embodiment of the present invention, the method of the present invention implements the process of program operation, and the specific examples of defining variables include:

[0266] 1. data: is the file name of the data set to be analyzed by the program. After the user fills in the name of the data set to be analyzed by the program after data=, the program will automatically call the blood drug concentration data set according to the filled name.

[0267] 2.bql: It is the form in which the "BQL" value is marked in the original data set. Generally, the "BQL" value in the blood drug concentration data set will be directly marked as "BQL". It is marked for other forms, and the user can fill in other forms here for the program to recognize. Note that the marked form of "BQL" should be enclosed in single or double quotation marks as explicitly in the above reference code.

[0268]3.nd: It is the form that the "BQL" after reaching Cmax needs to be co...

Embodiment 3

[0282] According to a specific embodiment of the present invention, taking the data in Table 1 as an example, provide the blood drug concentration of the drug clinical trial subjects at each blood collection time point before the method of the present invention is used and the data simulates a single administration. information. In the data, subj_id represents the subject number, conc represents the blood drug concentration, real_time represents the actual blood collection time point, time represents the planned blood collection time point, dose_group represents the subject’s dose group, treatment_group represents the subject’s treatment group, and 1 represents the test group, 0 represents the control group.

[0283] Table 1 Raw data set

[0284]

[0285]

[0286]

[0287]

[0288] The following is a code example of the method of the present invention called in the SAS system, and the implementation program of the method of the present invention is named "PKBQL Ma...

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Abstract

The invention provides a simplified analysis method and system for pharmacokinetic parameters, and belongs to the technical field of pharmacokinetics. According to the method, when pharmacokinetics ofa single administration test of a clinical drug test is analyzed, values which are in a data set and are lower than the lower limit of a measurement method and cannot be measured are subjected to self-defined conversion, and important parameter results such as Cmax, Tmax, the average blood concentration value of each dose group in a test group at each planned blood sampling time point and the like are obtained; an operation result is merged into the original data set under the condition that the format of the original data set and other variable data in the data set are not influenced and changed, and a new data set is generated or directly covers the original data set. Statists can simply use the method provided by the invention in SAS software to quickly obtain the required operation result, and can directly carry out subsequent analysis and research work without spending a lot of time in importing, merging or sorting data sets among different software.

Description

technical field [0001] The invention relates to the technical field of pharmacokinetics, in particular to a simplified analysis method and system for pharmacokinetic parameters. Background technique [0002] The pharmacokinetic analysis of drug clinical trials is mainly to analyze the blood drug concentration of each subject at each blood collection time point and extract the pharmacokinetic parameters. Among many pharmacokinetic parameters, Cmax and Tmax are among the most important parameters. Cmax represents the peak blood drug concentration of each subject, and Tmax represents the blood collection time point when the subject's blood drug concentration reaches the peak Cmax. [0003] When the statistician gets the blood drug concentration data of the subject, some blood drug concentration will be marked as "BQL", which means that the blood drug concentration data is lower than the quantitative lower limit of the measurement method and cannot be measured. Before analyzin...

Claims

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Application Information

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IPC IPC(8): G16H70/40G16C20/70
CPCG16H70/40G16C20/70
Inventor 闫硕
Owner 昭衍(北京)医药科技有限公司
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