解读《化学药物(原料药和制剂)稳定性研究技术指导原则》  

Interpretation of the guidance of stability testing of drug substances and products

作　　者：霍秀敏[1] 魏农农[1] 何伍[1] 马玉楠[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国临床药理学杂志》2014年第10期974-978,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：《化学药物(原料药和制剂)稳定性研究技术指导原则》是2005年国家食品药品监督管理局(SFDA)发布的《化学药物稳定性研究技术指导原则》的修订版。本文通过介绍该指导原则的修订背景,阐述修订的指导思想及主要内容,明晰与注册申报相关的概念,深度解读进行稳定性研究需关注的问题,以方便药品研发单位及生产企业理解,并在以后的稳定性试验设计及撰写注册申报资料时参考。The guidance of stability testing of drug substances and prod -ucts has been revised based on the previous version published by the State Food and Drug Administration [SFDA, now called China Food and Drug Administration（CFDA）] in 2005.This article will interpret the un-derlying principles and background information behind the guidance revi -sion, demonstrate the cognition and major revision points , clarify appli-cation -related concepts, and deeply elucidate the issues raised on drug stability research.This shall help drug developers and manufacturers to have better understanding of the guidance and shall serve as a reference for subsequent experimental designing and application document writing of drug stability tests.

关 键 词：原料药 制剂 稳定性 指导原则 

分 类 号：R954[医药卫生—药学]