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
CN112259251AActive Publication Date: 2021-01-22昭衍(北京)医药科技有限公司
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
昭衍(北京)医药科技有限公司
Publication Date
2021-01-22

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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.
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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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