Pharmacokinetic data management and statistics in a regulatory environment

目的 进行药代动力学数据管理、统计计算,使计算过程和结果满足法规的规范性、一致性和完整性要求.方法 采用流程化的方法进行数据管理和统计计算,其主要流程包括:确定需要提供的数据和格式、数据接受和审核、数据锁定、药代动力学数据的程序化统计计算、计算结果的审核和锁定、报告和存档.结果 从实际项目的运行情况看,采用流程化的数据管理方法,可以完整记录各项数据的节点,确保每次计算结果的准确性,减少错误率.结论 所建议的方法,具有数据轨迹清晰、溯源性强、效率高、重复计算方便等特点,能够满足目前法规的要求.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.中国科学引文数据库(CSCD)131248-12503