创新药物临床试验中暴露量-效应关系研究的探讨  

Consideration of exposure-response relationships during clinical trials of new drugs

作　　者：魏敏吉[1] 赵明[2] 单爱莲[1] 

机构地区：[1]北京大学第一医院临床药理研究所,北京100034 [2]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2011年第17期1608-1611,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(20082X09312-017)

摘　　要：创新药物临床试验旨在为药物上市提供安全有效的依据,涵盖了临床药理学研究、剂量探索性临床治疗试验和确证性临床治疗试验,其中暴露量-效应关系研究已经成为临床研究的核心。本文在梳理了创新药物临床试验的前后过程以及逻辑关系的基础上,对暴露量-效应关系研究的相关内容、暴露量-效应关系研究在审评、提高临床研究质量、降低临床失败风险以及加速新药上市方面的重要性方面进行了探讨。The purpose of clinical trial is to provide solid evidences on its effectiveness and safety of a new drug, which can be used by regulatory agencies to make approval decisions. Clinical trials contain studies on clinical pharmacology, dose-escalation, and proof of concepts, in which the exposure-response information is at the heart of any determination of the safety, and confirmative test. Based on the time course of clinical trials and their logic relationships, we in this paper discussed the information obtained from exposure-response studies as well as the importance of exposure-response relationships on the drug evaluation. Our goals are to improve the quality of clinical trials, lower the risk of clinical failure and accelerate the marketing of the drug products.

关 键 词：创新药物 临床试验 暴露量-效应关系 

分 类 号：R95[医药卫生—药学]