中国临床药理学杂志2017，Vol.33Issue(13)：1248-1250,3.DOI:10.13699/j.cnki.1001-6821.2017.13.022
符合法规要求的药代动力学数据管理和统计计算方法
Pharmacokinetic data management and statistics in a regulatory environment
魏敏吉 1单爱莲 1张朴1
作者信息
- 1. 北京大学第一医院临床药理研究所,北京100034
- 折叠
摘要
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.关键词
数据管理/药代动力学/生物等效性Key words
data management/pharmacokinetics/bioequivalence分类
医药卫生引用本文复制引用
魏敏吉,单爱莲,张朴..符合法规要求的药代动力学数据管理和统计计算方法[J].中国临床药理学杂志,2017,33(13):1248-1250,3.
