CAJ | 학술논문

《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。
《화학약물（원료약화제제）은정성연구기술지도원칙》시2005년국가식품약품감독관리국（SFDA）발포적《화학약물은정성연구기술지도원칙》적수정판。본문통과개소해지도원칙적수정배경，천술수정적지도사상급주요내용，명석여주책신보상관적개념，심도해독진행은정성연구수관주적문제，이방편약품연발단위급생산기업리해，병재이후적은정성시험설계급찬사주책신보자료시삼고。
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.