体内Pig-a基因突变试验方法的开发  

Progress of in vivo Pig-a gene mutation assay

作　　者：张铭 周长慧 王庆利[2] 常艳 

机构地区：[1]中国医药工业研究总院国家上海新药安全评价研究中心,上海201203 [2]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《世界临床药物》2012年第11期684-687,共4页World Clinical Drug

基　　金：国家"十二五"重大专项基金资助项目(2012ZX09505-001-003)

摘　　要：体内基因突变是遗传毒理试验中非常重要的检测终点。国际人用药物注册技术协调会议(ICH)新版遗传毒性指导原则的出台,对体内遗传毒性检测方法的发展提出了更高的要求。新的检测体细胞突变的体内实验方法即磷脂酰肌醇聚糖A(Pig-a)基因突变试验,有望成为一项新药遗传毒性评价的标准试验。本文简要综述Pig-a体内基因突变试验的特点及其在新品种开发遗传毒性检测中的应用。In vivo gene mutation is a key genetic toxicology endpoint.Recently,the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use（ICH） published genotoxic-guideline,more emphasis will be placed on the results of in vivo genotoxicity testing assays.In the recent years,a new in vivo genotoxicity tests have been developed,especially for the in vivo Pig-a gene mutation assay which is under international validation and potential to be a tool for regulatory safety assessment.This paper mainly reviews characteristics of the in vivo Pig-a gene mutation testing method and its application in the genotoxicity detection of new products.

关 键 词：磷脂酰肌醇聚糖A基因 遗传毒性 药物安全性 

分 类 号：R394.6[医药卫生—医学遗传学] R991[医药卫生—基础医学]