摘要
生理药代动力学(physiologically based pharmacokinetics,PBPK)模型是药物研究的一种重要数学建模方法。它可以利用临床前数据预测药物在人体内的药代动力学行为,也可以探索年龄、种族或疾病状态等各种生理参数对人体药代动力学的影响,指导给药剂量和用药方案,以及评估药物-药物相互作用。近十几年来,PBPK建模在学术界和医药界迅速发展,已被广泛运用于药物研发的各个阶段。本文简要介绍了PBPK建模的基本概念与方法 ,从药物处方前研究、剂型开发、食物效应、群体药代动力学及仿制药的生物等效性等方面讨论了其在药物制剂研发中的应用及前景。
Physiologically based pharmacokinetics (PBPK) model is an important mathematical modeling method for drug research. It can predict the pharmacokinetic behaviors of drugs in the human by using preclinical data, explore the impacts of various physiological parameters, such as age, race or disease status on human pharmacokinetics, guide on dosage and dosing regimens and evaluate drug-drug interactions. PBPK modeling has developed rapidly in the last decade within both the fields of academia and the pharmaceutical industry, which has been widely used in all stages of drug development. In this article, the concept and methodology of PBPK modeling are briefly introduced. Several cases are discussed on its application and prospect in the research and development of pharmaceutics, including preformulation. dosage form development, food effect, prediction of population pharmacokinetics, bioequivalence of generic drugs, etc.
作者
刘宏锐
陈芳
相小强
全应军
金莎莎
LIU Hongrui;CHEN Fang;XIANG Xiaoqiang;QUAN Yingjun;JIN Shasha(National Pharmaceutical Engineering Research Center, China,State Institute of Pharmaceutical Industry, Shanghai 201203;School of Pharmacy, Fudan University, Shanghai 201203;Fudan University Pudong Medical Center, Shanghai 201300)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2019年第4期383-391,共9页
Chinese Journal of Pharmaceuticals
基金
上海市科委研发平台建设专项(18DZ2290500)
复旦大学附属浦东医院-复旦大学药学院战略合作融合基金(RHJJ2017-05)
2型糖尿病相关基因apelin遗传多态性及其表达的调控(15411970700)
关键词
生理药代动力学
建模
药物研究
药剂学
physiologically based pharmacokinetics (PBPK)
modeling
drug development and research
pharmaceutics
