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

VernacularTitle:解读《化学药物（原料药和制剂）稳定性研究技术指导原则》
Author: Xiu-Min HUO ¹ ; Nong-Nong WEI ; Wu HE ; Yu-Nan MA
Author Information

1. 国家食品药品监督管理总局药品审评中心
Keywords: drug substance; drug product; stability; guidance
From: The Chinese Journal of Clinical Pharmacology 2014;(10):974-978
CountryChina
Language:Chinese
Abstract: 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.