Pharmacokinetic data management and statistics in a regulatory environment
10.13699/j.cnki.1001-6821.2017.13.022
- VernacularTitle:符合法规要求的药代动力学数据管理和统计计算方法
- Author:
Min-Ji WEI
1
;
Ai-Lian SHAN
;
Pu ZHANG
Author Information
1. 北京大学第一医院临床药理研究所
- Keywords:
data management;
pharmacokinetics;
bioequivalence
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(13):1248-1250
- CountryChina
- Language:Chinese
-
Abstract:
Objective Perform pharmacokinetic data management,calculation and statistics to meet the current regulatory requirements for good practice,consistence and integrity of the data.Methods A method with flow diagrams was proposed and used for the pharmacokinetic data management and statistics.It mainly includes:data and their format,data receiving and checking,data lock,pharmacokinetic calculation and statistics,results reviewing and locking,reporting and archiving.Results Experiences from real world cases indicated data management with flow diagrams could accurately record the time events for every task,guarantee the accuracy of each calculation,and minimize errors.Conclusion The proposed method has the advantages of easy tracking,consistence,high efficiency and easy re-calculation etc,and could meet the current regulatory requirements.
