方法变更的分类和接受标准与评估方式探讨  

Discussion on the classification,acceptance criteria and assessment approaches of the change of analytical procedure

作　　者：朱容蝶 耿颖[2] 杜颖 谭德讲[2] 陈华[2] 邱志均 ZHU Rong-die;GENG Ying;DU Ying;TAN De-jiang;CHEN Hua;QIU Zhi-jun(Beijing Union Pharmaceutical Factory LTD,Beijing 102629,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]北京协和药厂有限公司,北京102629 [2]中国食品药品检定研究院,北京102629

出　　处：《药物分析杂志》2024年第4期562-566,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：方法变更作为方法全生命周期中的一环,随着新技术的不断涌现,对产品质量需求的不断提高,3R和环境保护以及降低成本等要求的不断增加,越来越受到重视。本文参考国内外对方法学研究的最新进展,从方法学角度对方法变更进行系统的类别划分,并对不同方法变更类型间的差异和对变更后方法的评价标准和实施方式进行探讨。The change of analytical procedure,a part of the entire lifecycle of a method,is increasingly valued with the emergence of new technologies,the increasing demand for product quality,3R,environmental protec⁃tion,and cost reduction requirements.This paper refers to the latest progress in the study of counterpart law at home and abroad,systematically classifies changes of analytical procedures from the perspective of methodology,and discusses the differences between different types of changes and the evaluation criteria and implementation ap⁃proaches of analytical procedures after procedure changes.

关 键 词：方法变更 方法替代 方法转移 方法改进 等效性检验 非劣效性检验 预测区间 容忍区间 

分 类 号：R917[医药卫生—药物分析学]