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
朱容蝶 1耿颖 2杜颖 2谭德讲 2陈华 2邱志均1
作者信息
- 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
- 折叠
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.
Abstract
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Key words
change of analytical procedure/alternative of analytical procedure/transfer of analytical procedure/improvement of analytical procedure/equivalence test/non-inferior test/prediction interval/tolerance interval引用本文复制引用
出版年
2024
NETL
NSTL
万方数据