美国药物基因组学指南概述及对我国的启示

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.%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.