生理药动学模型发展现状及其在药物临床研究中的应用  

Current development of physiologically based pharmacokinetic model and its application in drug clinical study

作　　者：沈淑娇 樊玉娟 裘福荣 严东明 SHEN Shujiao;FAN Yujuan;QIU Furong;YAN Dongming(Department of Traditional Chinese Medicine, Taizhou Municipal Hospital, Taizhou 318000, Zhejiang, China;Clinical Pharmacokinetics Laboratory of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;Yangzijiang Shanghai Haini Pharmaceutical co., LTD, Shanghai 201308, China)

机构地区：[1]台州市立医院中药科,浙江台州318000 [2]上海中医药大学附属曙光医院临床药代动力学实验室,上海201203 [3]扬子江药业上海海尼药业有限公司,上海201318

出　　处：《中国临床药理学与治疗学》2020年第3期334-343,共10页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家自然科学基金(81874364);十三五“重大新药创制GCP平台建设(2017ZX09304002)”;上海市进一步加快中医药事业发展三年行动计划(ZY(2018-2020)-CCCX-2003-10)资助项目;台州市椒江区科技计划项目(172049)。

摘　　要：生理药动学(physiologically based pharmacokinetic,PBPK)模型是一种基于生理机制的模型,能够模拟药物在体内的吸收、分布、代谢和排泄过程。近年来广泛应用于药物-药物相互作用研究、外推特殊人群、临床试验剂量的选择、个体化用药及研究不同因素对药动学过程的影响等领域。本文对PBPK模型发展现状进行简述,简要介绍PBPK模型的应用流程,并对其近年来在药物临床研究中的应用情况进行综述,以期为对该领域感兴趣的研究人员提供参考。The physiologically based pharmacokinetic(PBPK)model,as a physiological mechanism-based model,can simulate the absorption,distribution,metabolism and excretion of drugs in the body.In recent years,it has been widely used in drug-drug interaction study,special population extrapolation,clinical trial dose selection,individualized medication and impact of different factors on the pharmacokinetic course.This review briefly describes the history and current development of PBPK model,introduces the work flow of PBPK model,and reviews its application in drug clinical study in recent years.We hope this review could provide a reference for researchers who are interested in this field.

关 键 词：生理药动学模型 药物临床研究 药物-药物相互作用 特殊人群 

分 类 号：R969.1[医药卫生—药理学]