药品分析方法转移类型与程序  

Types and procedures of the transfer of drug analytical methods

作　　者：孙一平[1] 刘戈[1] 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)

机构地区：[1]上海现代制药股份有限公司上海事业部,上海200137 [2]上海现代制药海门有限公司,江苏海门226133

出　　处：《上海医药》2019年第3期74-77,共4页Shanghai Medical & Pharmaceutical Journal

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.

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 

分 类 号：R917[医药卫生—药物分析学]