药物基因组学在新药临床研究中的应用现状  

Application status of pharmacogenomics in clinical researches of new drugs

作　　者：张晓丹[1] 向倩[1] 胡琨[1] 赵侠[1] 崔一民[1] 

机构地区：[1]北京大学第一医院药剂科,北京100034

出　　处：《中国临床药理学杂志》2017年第23期2508-2510,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：药物基因组学(PGx)主要研究基因多态性等遗传特性对药物代谢、药效和药物不良反应的影响,旨在为新药研发、临床试验、注册上市、个体化药物治疗提供科学依据。随着制药行业的蓬勃发展,药物基因组学已经在新药研发和上市药品再评价的临床研究中获得越来越多的应用。药物基因组学可以大大缩短药物开发周期,降低新药研究成本,有助于优化药品的临床应用方案,提高药物临床应用的安全性和有效性。本文针对药物基因组学在临床研究各阶段中的具体应用及其发展展望等内容进行综述。Pharmacogenomics（ PGx） mainly studies the influence of gene polymorphisms and other genetic characteristics on drug metabolism,efficacy and adverse drug reactions,and aims to provide scientific basis for new drug research and development,clinical trials,registration,and indivi-dualized drug therapy. With the vigorous development of the pharmaceutical industry,PGx has been more and more applied not only in the research and development of new drugs but also in drug post-marketed re-evaluation. PGx can greatly shorten the drug development cycle,reduce the cost of new drug research,and help to optimize the clinical application of drug therapy to improve safety and efficacy. This paper reviews on the specific application of PGx in various stages of clinical research and its developmental prospect.

关 键 词：药物基因组学 新药研发 临床研究 临床试验 

分 类 号：R97[医药卫生—药品]