基于生物药剂学分类系统的生物等效性豁免指导原则草案

Draft guidance of biopharmaceutics classification system-based biowaivers

参考ICH M9指导原则,提出对《中国药典》制剂生物等效性指导原则中,增加有关生物等效性豁免的内容草案。包括生物药剂学分类系统的简要介绍,辅料对药物吸收的影响,体外溶出度比较,制剂生物等效性豁免的必要条件,以及数据提交。这将有助于ICH标准的转化实施,通过体外实验得到关键数据,避免昂贵的人体试验,从而节约成本且更符合伦理。

Referring to the ICH M9 guideline,a draft of bioequivalence exemption is proposed to be added to the guidance of preparation bioequivalence in the Chinese Pharmacopoeia.It includes an introduction to the biopharmaceutical classification system,the impact of excipients on drug absorption,in vitro dissolution comparison,the necessary conditions for bioequivalence exemption of preparations,and data submission.This will contribute to the transformation and implementation of ICH standards.Key data can be obtained through in vitro experiments to avoid expensive human experiments,thus saving costs and being more ethical.