美国药物基因组学指南概述及对我国的启示

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (11): 662-665.

美国药物基因组学指南概述及对我国的启示

王涛, 宋海波, 董铎

国家食品药品监督管理总局药品评价中心,北京 100045

收稿日期:2017-12-26 修回日期:2017-12-26 出版日期:2017-11-20 发布日期:2017-12-26
作者简介:王涛,男,博士,副研究员,神经药理学、药品不良反应监测与评价。
基金资助:
国家科技重大专项（2017ZX09101001-001-003）：药品再评价政策法规及实施策略研究

Brief Introduction of Guidance on Pharmacogenomics in the USA and Its Implication for China

WANG Tao, SONG Hai-bo, DONG Duo

Center for Drug Reevaluation, CFDA, Beijing 100045, China

Received:2017-12-26 Revised:2017-12-26 Online:2017-11-20 Published:2017-12-26

摘要/Abstract

摘要： 目的对美国药物基因组学指南的类别、用途、内容等进行系统梳理和介绍,以期推进药物基因组学在我国的应用。方法查询中外文献和美国食品药品监督管理局（FDA）官网有关药物基因组学的指南文件。结果美国FDA针对基因组学取样和样本编码、药物基因组学数据提交、数据管理以及数据在上市前研究和上市后评价中的应用发布了一系列较为完善的配套指南,本文以《临床药物基因组学：早期临床研究的上市前评价和说明书推荐》指南为例,对其药物基因组学相关概念和背景、说明书药物基因组学信息的纳入和附录（实例）三章进行了详细介绍。结论美国药物基因组学指南可为我国的新药研发及上市后药品风险管理提供参考。

关键词: 药物基因组学, 指南, 不良反应

Abstract: Objective To classify and introduce the FDA's guidance on pharmacogenomics and provide suggestions to conduct the application of pharmacogenomics in China. Methods The materials of guidance on pharmacogenomics in FDA official website were researched, and the related literatures were searched and analyzed. Results FDA has issued a series of guidance on genomic sampling, sample coding, data submission, studies in clinical trials and recommendations for labeling to ensure the application of pharmacogenomicsin the USA In this section, the guidance Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling was elaborated as a case here, and three chapters were emphatically introduced. Conclusion The FDA's guidance on pharmacogenomics could give us valuable reference for new drug development and post-marketing drug evaluation.

Key words: pharmacogenomics, guidance, adverse reaction

中图分类号:

王涛, 宋海波, 董铎. 美国药物基因组学指南概述及对我国的启示[J]. 中国药物警戒, 2017, 14(11): 662-665.

WANG Tao, SONG Hai-bo, DONG Duo. Brief Introduction of Guidance on Pharmacogenomics in the USA and Its Implication for China[J]. Chinese Journal of Pharmacovigilance, 2017, 14(11): 662-665.

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