药物基因组学在新药临床试验及个体化用药中的应用  

Application of Pharmacogenomics in Clinical Trials of New Drugs and Individualized Administration

作　　者：耿春梅[1] 郭瑞臣[1] 

机构地区：[1]山东大学齐鲁医院临床药理学研究所,山东济南250012

出　　处：《药学进展》2015年第11期803-809,共7页Progress in Pharmaceutical Sciences

摘　　要：药物安全性和有效性评价是药物临床试验和个体化用药的核心,也是药物基因组学研究的主要内容。药物基因组学研究贯穿于药物研发、上市评价和临床应用整个过程,根据药物代谢酶、转运体、受体相关基因多态性对用药者进行分层分析,评价与药物体内的处置过程、安全性、有效性个体差异的相关性。综述药物基因组学在新药临床试验、个体化用药中的应用研究新进展。Evaluation of drug safety and efficacy is the core issue in clinical trials and individualized administration, which is also the main content of pharmacogenomics. Pharmacogenomics is related to the whole process of drug research, evaluation and clinical application, and can be used to evaluate individual differences in drug disposition, efficacy and safety via analyzing gene polymorphisms of metabolic enzymes, transporters and receptors in patient and health subjects. Advances in the application of pharmacogenomics in clinical trials of new drugs and individualized administration were reviewed in this article.

关 键 词：药物基因组学 有效性 安全性 临床试验 个体化用药 

分 类 号：R969[医药卫生—药理学]