调释制剂仿制药生物等效性研究要求  

Requirements for Bioequivalence Study of Modified-Release Generic Drugs

作　　者：马婧怡 李敏[1] 王骏[1] MA Jing-yi;LI Min;WANG Jun(Centre for Drug Evaluation,National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2021年第8期34-39,共6页China Food & Drug Administration Magazine

摘　　要：国内外监管机构对于调释制剂仿制药的生物等效性研究发布了相关指导原则。本文通过对国家药品监督管理局、美国食品药品监督管理局和欧洲药品管理局相关指导原则汇总分析,以期为我国调释制剂仿制药研发提供参考。Drug regulators in China and abroad have issued various guidelines for the bioequivalence study of modifiedrelease generic drugs.This article summarizes and analyzes the relevant guidelines of NMPA,FDA and EMA,in order to provide reference for the research and development of modified-release generic drugs in China.

关 键 词：调释制剂 仿制药 生物等效性 监管 

分 类 号：R95[医药卫生—药学]