随着科学认知的不断深入，为缩短药品的批准上市时间，不同药品监管机构相继出台了人体生物等效性豁免的相关法规及技术文件，旨在通过体外研究来替代体内试验。总结和比较国内外相关指导原则对速释口服固体剂型的仿制药药学研究的要求，重点关注存在的差异之处，探讨背后的科学原因，并在最终经国际人用药品注册技术协调委员会协调一致的过程中得到思考和启示，以期增加仿制药被豁免体内试验的成功率、进而降低仿制药的开发成本，但同时亦能保证其质量和疗效与参比制剂一致，真正实现其临床可替代性。

With the deepening of scientific cognition, in order to shorten the time of the drug marketed process, different regulatory agencies have successively issued relevant regulations and guidance on biowaivers (BE) to replace in vivo BE study with in vitro tests. This paper is aimed to summarize and compare the requirements of relevant guidances at home and abroad for generic pharmaceutical research of immediate-release oral solid dosage forms, focuse on the differences, explore the possible scientific reasons behind, and finally get thinking and inspiration in the process of coordination by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), expected to increase the success rate of generics being waived in vivo study, thus reducing the development cost of generic drugs. Meanwhile, the quality and efficacy of generics is ensured that consistent with reference products, so as to truly realize their clinical substitutability.

R944.2