摘要
本文从分析方法转移与方法验证和确认的概念着手,介绍其区别与不同适用范围。着重论述分析方法转移的方式和程序,并探讨了分析方法转移中的实验设计与接收标准。
This article started with the concept of transfer, validation and confirmation of analytical methods and introduced its differences and different scopes of application. Meanwhile, the methods and procedures for the transfer of analytical methods were focused on and the experimental design and acceptance criteria in the transfer of analytical methods were also explored.
作者
孙一平
刘戈
李春刚
SUN Yiping;LIU Ge;LI Chungang(Shanghai Shyndec Pharmaceutical Co., Ltd., Shanghai 200137, China;Shanghai Shyndec Pharmaceutical (Haimen) Co., Ltd., Jiangsu Haimen 226133, China)
出处
《上海医药》
CAS
2019年第3期74-77,共4页
Shanghai Medical & Pharmaceutical Journal
关键词
分析方法转移类型
对比试验
分析方法转移程序
实验设计
接收标准
types of transfer of analytical methods
comparative test
transfer of analytical method
experimental design
acceptance criteria