生物药剂分类系统(BCS)及应用进展介绍

Introduction of biopharmaceutics classification system(BCS) and its application progress

生物药剂分类系统是根据药物的溶解性和渗透性对药物进行分类的一种科学框架,目前FDA、WHO和EMEA都接受了这种分类概念。文中比较了不同管理当局对于生物药剂分类系统(BCS)的定义以及BCS在药品注册申报中支持生物等效免除的应用情况,综述了不同管理当局对于BCS的认识并提出了展望。

Biopharmaceutics classification system （BCS） is a scientific frame based on the solubility and permeability of drugs. Currently, FDA, WHO and EMEA have accepted the concept of BCS. In this review, we compared the criteria of BCS in different regulatory agencies, presented biowaiver applications based on BCS and the regulatory experience gained up to date, and expected future trends.