| FDA对药物基因组学早期临床研究的建议 |
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| 引用本文： | 赵德恒,萧惠来. FDA对药物基因组学早期临床研究的建议[J]. 金属学报, 2015, 20(2): 208-212 |
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| 作者姓名： | 赵德恒 萧惠来 |
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| 作者单位： | 国家食品药品监督管理总局药品审评中心,北京 100038 |
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| 摘 要： | 药物基因组学是当前一个热点话题。FDA于2013年发布了“临床药物基因组学指导原则:早期临床研究的上市前评价和对说明书的建议”, 本文介绍其中第IV部分基因组学的临床评价。我国还没有类似的指导原则,期待本文对我国这方面的研究和监管有益。
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| 关 键 词： | FDA 指导原则 药物基因组学 早期临床研究 研究设计 |
| 收稿时间： | 2013-07-02 |
| 修稿时间： | 2014-03-14 |
FDA's recommentdations on pharmacogenomics studies in early-phase clinical studies |
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| ZHAO De-heng,XIAO Hui-lai. FDA's recommentdations on pharmacogenomics studies in early-phase clinical studies[J]. Acta Metallurgica Sinica, 2015, 20(2): 208-212 |
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| Authors: | ZHAO De-heng XIAO Hui-lai |
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| Affiliation: | Center for Drug Evaluation, China Food and Drug Administration,Beijing 100038,China |
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| Abstract: | Pharmacogenomics is currently a hot topic. FDA issued “Guidance for Industry Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling” in 2013. The article introduces its IV Clinical Evaluation of Pharmacogenomics. There is no similar guidance in our country. It is expected to benefit the research and supervision of our country in this respect. |
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| Keywords: | FDA guidance pharmacogenomics early-phase clinical studies study design |
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