药物相互作用研究在新药研发和审评决策中的应用  

Applications of drug interaction study in new drug development and regulartory decision-making

作　　者：孙搏 付淑军 陈桂良 李丽 SUN Bo;FU Shujun;CHEN Guiliang;LI Li(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China;Center for Drug Evaluation,National Medical Products Adminstration,NMPA,Beijing 100038,China)

机构地区：[1]上海药品审评核查中心,上海201203 [2]国家药品监督管理局药品审评中心,北京100038

出　　处：《中国临床药理学与治疗学》2021年第10期1095-1102,共8页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：重大新药创制科技重大专项(2017zx09101001)。

摘　　要：药物相互作用改变了剂量效应关系,可能会降低疗效或增加毒性,是临床应用中合并用药治疗时重要的考虑因素。预测具有临床意义的药物相互作用是药物研发过程中获益风险评估的重要环节。本文概述了药物研发过程中药物相互作用研究的目的和意义,体内和体外研究的主要内容,梳理分析了2020年国家药品监督管理局(National Medical Products Administration,NMPA)和美国食品药品监督管理局(Food and Drug Administration,FDA)批准上市的新药药物相互作用研究情况,旨在为我国药物研发过程中药物相互作用研究及其监管审评提供参考。Drug-drug interactions(DDI)change dose-response relationships,and may result in low efficacy or high toxicity,which are important considerations especially in medical practice with multiple-drug therapies.Predicting clinically significant drug interactions during new drug development is an important part of benefit and risk assessment in drug development and review.This article summarizes the purpose and significance of drug interactions in new drug development,the main content and precautions of DDI studies in vivo and in vitro.Drug interaction studies on novel drug approvals for 2020 in the National Medical Products Administration(NMPA)and US Food and Drug Administration(USFDA)are examined,respectively.It aims to provide reference for DDI studies and regulatory reviews in new drug development in our country.

关 键 词：药物相互作用 药物研发 新药审评 国家药品监督管理局 美国食品和药物管理局 

分 类 号：R969[医药卫生—药理学]