摘要
药物的体内外相关性(IVIVC)研究常用于口服固体制剂的研发,建立相关性模型的目的是通过体外的释放度试验结果来预测药物在人体的吸收情况。近年来,常有申报单位因产地变更或增加规格等而报送体内外相关性研究的有关资料以豁免法规要求的生物等效性试验,本文探讨了对体内外相关性研究进行技术审评的一些主要关注点。
The in vitro-in vivo correlation（IVIVC） model is often established for the oral solid extended release drug product development in order to predict accurately and precisely the expected bioavailability characteristics for the product from dissolution profile characteristics study.In the past several years,CDE occasionally received IVIVC documents for applying waiver of in vivo bioequivalence study when it is necessary to document bioequivalence because of post-approval changes（e.g.,formulation,strength,manufacturing site changes,etc.）.This paper discussed the key points in the IVIVC development program and introduced the considerations from CDE perspective in reviewing these applications.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2007年第9期961-964,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
关键词
体内外相关性
技术审评
in vitro-in vivo correlation
drug evaluation
