药品分析方法转移类型与程序

Types and procedures of the transfer of drug analytical methods

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.