中国临床药理学杂志2017，Vol.33Issue(17)：1728-1732,5.DOI:10.13699/j.cnki.1001-6821.2017.17.033
基于生理的药代动力学模型在创新药临床研发中的应用进展
Application progress of physiologically-based pharmacokinetic model in clinical development of novel molecular entities
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
By integrating human physiological parameters,drug chemical/physical data,and drug mechanistic pharmacokinetic data,physiologically-based pharmacokinetics model (PBPK) can be used to predict pharmacokinetic/pharmacodynamics characteristics in subjects under various clinical conditions (e.g.different dose regimen,specific population).As such,PBPK prediction supports efficient,faster and safe clinical development of novel molecular entities.Recently,PBPK analyses have been extensively applied in new drug development in US and Europe,where relevant guidance documents have been released to direct PBPK study.In this review,we will introduce the application of PBPK model in clinical development of new drug and hopefully to update knowledge in PBPK study and support new drug development in our country.关键词
基于生理的药代动力学模型/创新药/临床研发Key words
physiologically-based pharmacokinetic model/novel moiety entities/clinical development分类
医药卫生引用本文复制引用
李丽,杨进波..基于生理的药代动力学模型在创新药临床研发中的应用进展[J].中国临床药理学杂志,2017,33(17):1728-1732,5.
