中国临床药理学与治疗学2017，Vol.22Issue(9)：961-965,5.
基于生理的口服吸收模型在仿制药研发中的应用和趋势
Application and progress of physiologically-based oral absorption model in clinical development of generic drugs
李丽 1杨进波1
作者信息
- 1. 国家食品药品监督管理总局药品审评中心,北京100038
- 折叠
摘要
Abstract
Demonstration of in vitro in vivo correlation (IVIVC) could identify key factors of pharmaceutical characteristics affecting drug efficacy,quality,stability,and safety.Compared with compartmental model-based deconvolution method,physiologically-based oral absorption model could better establish IVIVC by separating kinetics of permeability,metabolism,and transportation.Currently,physiologically-based oral absorption model has been extensively employed by big pharmaceutical companies in US and Europe to develop new formulation and support clinical bioequivalence (BE) trials.It is one of the major tools to simplify development of generic drugs and to evaluate the quality of generic drug application utilized by Food and Drug Administrator (FDA) in US.Regarding the regulatory need of Abbrevitive New Drug Application (ANDA) and generic drug consistency evaluation in China,we reviewed the application progress,investigation strategy,challenges,and regulatory utility of physiologically-based oral absorption model to support generic drug development in China.关键词
基于生理的口服吸收模型/仿制药Key words
physiologically-based oral absorption model/generic drugs分类
医药卫生引用本文复制引用
李丽,杨进波..基于生理的口服吸收模型在仿制药研发中的应用和趋势[J].中国临床药理学与治疗学,2017,22(9):961-965,5.
