PBPK模型及其在生物等效性研究中的应用进展  

Characteristics and applications in bioequivalence of physiologically based on pharmacokinetic model

作　　者：王建雄 胡晓[1] 苗贝贝 张兰[1] WANG Jianxiong;HU Xiao;MIAO Beibei;ZHANG Lan(Department of Pharmacology,Xuanwu Hospital of Capital Medical University,National Clinical Research Center for Geriatric Diseases,Beijing Engineering Research Center for Nerve System Drugs,Beijing Institute of Brain Disorders,Key Laboratory of Neurodegenerative Diseases,Ministry of Education,Beijing 100053,China)

机构地区：[1]首都医科大学宣武医院药学部、国家老年疾病临床研究中心、北京市神经药物工程技术研究中心、北京脑重大疾病研究院、神经变性病教育部重点实验室,北京100053

出　　处：《中国临床药理学与治疗学》2025年第2期244-250,共7页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：“重大新药创制”科技重大专项(2017ZX09101-001-002-044);首都卫生发展科研专项(首发2022-2Z-20113);北京市医院管理中心“登峰”计划专项(DFL20190803)。

摘　　要：生理药代动力学模型(PBPK)是一种模拟药物在体内的吸收、分布、代谢和排泄过程的工具,目前在药物研究及监管中得到广泛应用。在仿制药一致性评价或药物生产工艺变更时的生物等效性评价中,PBPK模型可通过模拟药物的体内行为,为药物的生物等效性提供一定参考,同时可为药物生物等效豁免提供理论支持,从而促进更安全、更经济地进行药物临床试验。本文将综述PBPK模型在生物等效性研究中的应用进展,以期为我国药物临床研究提供支持。Physiologically based pharmacokinetics(PBPK)model is a tool to simulate the process of drug absorption,distribution,metabolism and excretion in vivo.It is widely used in drug research and regulation.In the bioequivalence evaluation of generic drug consistency evaluation and drug production process change,the PBPK model can provide a certain reference and theoretical support for the drug bioequivalence,thereby promoting safer and more economic drug clinical trials.In this paper,the application progress of PBPK model in bioequivalence study will be reviewed in order to provide support for clinical research on drugs in China.

关 键 词：PBPK模型 生物等效性 生物药剂学分类系统 仿制药一致性评价 PBBM模型 

分 类 号：R969[医药卫生—药理学]