群体药代动力学及其在新药研究中的应用  

Population pharmacokinetics and its application in new drug development

作　　者：盛玉成[1] 郑青山[1] 

机构地区：[1]安徽省药物临床评价中心

出　　处：《中国临床药理学与治疗学》2004年第12期1333-1337,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：近年来新药临床研究越来越重视群体药代动力学的应用。群体药代动力学可以定量地描述病理、生理、合并用药等多种因素对药物代谢的影响 ,可将PK参数中的各种变异区分开 ,指导用药方案的调整 ,从而增强对新药有效性和安全性的评价。本文对群体药代动力学的研究方法及其在新药研究中的应用进行综述。There is an increasing focus on the application of populatio n pharmacokinetics(PPK) in new drug development. The population PK approach can quantitative explore relationships among the pharmacokinetics, pathophysiologic features and concomitant medications. The variability of PK parameters within th e population can be estimated and dosages can be appropriately modified, and thi s approach can increase the evaluation of safety and efficacy for the new drug. This article reviews the approach of population pharmacokinetics and its applica tion in new drug develepment.

关 键 词：药代动力学 群体药代动力学 非线性混合效应模型法 数学模型 固定效应 

分 类 号：R969.1[医药卫生—药理学]