摘要
方法的分析目标概要(ATP)是药品分析方法研发和全生命周期管理中的关键内容,该内容在2022年最新发布的ICH Q14和USP〈1220〉中明确提出。本文结合国内外对分析方法全生命周期研究的最新进展,详细探讨了ATP的建立步骤,即:(1)收集相关先验知识。(2)根据所需检测的相关关键质量属性(CQA),确定需报告的方法性能特性。(3)研究并制定相应性能特性的接受标准。(4)采用回顾性研究方式构建已有方法的ATP。(5)ATP的优化更新。期望本文能为国内外方法学研究者提供参考,为分析方法的建立和全生命周期评估带来便利。
The analytical target profile(ATP)of analytical procedure is the key content in the development of analytical procedure and even the whole life cycle management,and the content had been explicitly proposed in the latest release of ICH Q14 and USP<1220 in 2022.The steps of establishing ATP were discussed in detail in this paper based on the latest research progress in the whole life cycle of analytical procedure at home and abroad,which included:①Collect relevant prior knowledge.②Determine the performance characteristics of the procedure to be reported according to the relevant critical quality attribute(CQA)to be detected.③Study and formulate the acceptance criteria of corresponding performance characteristics.④Construct the ATP of existed analytical procedure using retrospective research.⑤Optimize and update the primary ATP.It is expected that the paper could provide reference for methodological researchers at home and abroad and bring convenience to the development and evaluation for the whole life cycle of analytical procedure.
作者
杨美玲
孙佳敏
韩璐
耿颖
杜颖
杭太俊
谭德讲
YANG Mei-ling;SUN Jia-min;HAN Lu;GENG Ying;DU Ying;HANG Tai-jun;TAN De-jiang(NMPA Key Lab for Quality Research and Evaluation of Chemical Drug,National Institutes for Food and Drug Control,Beijing 102629,China;China Pharmaceutical University,Nanjing 210009,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第22期2293-2299,共7页
Chinese Journal of New Drugs
基金
国家药品标准制修订课题(2022Y09)
中国食品药品检定研究院质量安全与能力建设项目。
关键词
分析目标概要
方法生命周期
方法验证
方法确认
方法建立
analytical target profile
life cycle of analytical procedure
validation of analytical procedure
verification of analytical procedure
analytical procedure development
作者简介
杨美玲,女,硕士研究生,主要从事药品检测、方法学和质量标准研究。E-mail:meilingyang98@163.com;通讯作者:谭德讲,男,主任技师,硕士生导师,主要从事药理学、药品质量评价和非临床统计应用研究。联系电话:(010)53851581,E-mail:tandj@nifdc.org.cn。
