| 药物遗传毒性研究相关要求进展 |
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| 引用本文： | 黄芳华,王庆利. 药物遗传毒性研究相关要求进展[J]. 中国新药杂志, 2010, 0(6) |
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| 作者姓名： | 黄芳华 王庆利 |
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| 作者单位： | 国家食品药品监督管理局药品审评中心; |
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| 摘 要： | 遗传毒性研究是药物非临床安全性评价的重要内容。人用药品注册技术要求国际协调会(ICH)对药物遗传毒性指导原则进行修订改版,于2008年颁布了S2(R1)人用药物遗传毒性试验和结果分析指导原则,该指导原则对于我国药物遗传毒性研究具有借鉴作用。文中简介了该指导原则修订的科学背景、主要修订内容,并讨论了目前我国药物遗传毒性研究中应关注的几个问题。
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| 关 键 词： | 药物遗传毒性 非临床安全性评价 人用药品注册技术要求国际协调会 |
Advance of drug genotoxicity |
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| HUANG Fang-hua,WANG Qing-li. Advance of drug genotoxicity[J]. Chinese Journal of New Drugs, 2010, 0(6) |
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| Authors: | HUANG Fang-hua WANG Qing-li |
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| Affiliation: | HUANG Fang-hua,WANG Qing-li(Center for Drug Evaluation,State Food , Drug Administration,Beijing 100038,China) |
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| Abstract: | Genotoxicity study is one main components of nonclinical safety evaluation for drugs.Recently,the International Conference on Harmonization of the technical requirements for registration of pharmaceuticals for human use(ICH) revised the guidance for genotoxicity study,and released the ICH S2(R1) guidance on genotoxicity determination and data interpretation for pharmaceuticals intended for human use(Draft) in 2008.The article presented the scientific background of the revision and the major changes in the g... |
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| Keywords: | genotoxicity study nonclinical safety evaluation International Conference on Harmonization of the technical requirements for registration of pharmaceuticals for human use(ICH) |
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