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中国临床药理学与治疗学 ›› 2007, Vol. 12 ›› Issue (9): 961-964.

• 专论 •    下一篇

从技术审评角度看药品的体内外相关性研究

黄钦, 马玉楠   

  1. 国家食品药品监督管理局药品审评中心, 北京100038
  • 收稿日期:2007-09-26 修回日期:2007-10-05 出版日期:2007-09-26 发布日期:2020-10-30
  • 作者简介:黄钦, 男, 医学博士, 从事药品技术审评工作。Tel:010-68585566-516 E-mail:huangq@cde.org.cn

In vitro-in vivo correlation (IVIVC):perspectives from CDE reviewer

HUANG Qin, MA Yu-nan   

  1. Center For Drug Evaluation, State Food And Drug Administration, Beijing 100038, China
  • Received:2007-09-26 Revised:2007-10-05 Online:2007-09-26 Published:2020-10-30

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。

关键词: 体内外相关性, 技术审评

Abstract: 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.

Key words: in vitro-in vivo correlation, drug evaluation