| 体内Pig-a基因突变试验方法的开发 |
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| 引用本文： | 张铭,周长慧,王庆利,常艳.体内Pig-a基因突变试验方法的开发[J].世界临床药物,2012,33(11):684-687. |
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| 作者姓名： | 张铭 周长慧 王庆利 常艳 |
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| 作者单位： | 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 |
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| 基金项目： | 国家"十二五"重大专项基金资助项目 |
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| 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。
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| 关 键 词： | 磷脂酰肌醇聚糖A基因 遗传毒性 药物安全性 |
Progress of in vivo Pig-a gene mutation assay |
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| ZHANG Ming
,
ZHOU Chang-hui
,
WANG Qing-li
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CHANG Yan.Progress of in vivo Pig-a gene mutation assay[J].WORLD CLINICAL DRUGS,2012,33(11):684-687. |
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| Authors: | ZHANG Ming ZHOU Chang-hui WANG Qing-li CHANG Yan |
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| Institution: | 1(1 China State Institute of Pharmaceutical Industry National Shanghai Center for New Drug Safety Evaluation & Research, Shanghai 201203,China;2 Center for Drug Evaluation,State Food and Drug Administration,Beijing 100038,China) |
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| Abstract: | 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. |
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| Keywords: | Pig-a gene genotoxicity drug safety |
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