张伟国.个体化用药时代的新药研发[J].药物评价研究,2015,38():1-7
个体化用药时代的新药研发
Research and development of new drug in era of personalized medicine
投稿时间:2014-12-15  
DOI:
中文关键词:  个体化用药;新药研发;药物不良反应;药物基因组学
英文关键词:personalized medicine; new drug research and development; drug adverse reaction; pharmacogenomics
基金项目:
作者单位
张伟国 1. 天津中医药大学第二附属医院,天津 300150 
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中文摘要:
      近年来药物不良反应引起全球的关注。伴随着药物基因组学的发展,为了提高用药的精准性和有效性,2013年10月美国食品与药品监督管理局(FDA)发布了“为个体化用药铺平道路—FDA在医疗产品发展新时代中的作用”的报告。在解读该报告基础上,从个体化用药的定义以及实现条件两方面阐释了个体化用药的新内涵,并简要分析了个体化用药新时代背景下的新药研究和应用概况,以及所面临的机遇和挑战。同时对我国个体化用药的发展现状和亟待解决的问题进行分析,旨在为我国的新药研发以及个体化给药的顺利推进提供借鉴和参考。
英文摘要:
      Inrecent years, drug adverse reaction (ADR) has been paid more attention all over the world. With the aim of improving drug effectiveness and accuracy, the US Food and Drug Administration (FDA) issueda report titled “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development” in October 2013. On the basis of thoroughly interpretation of the report, new connotation of personalized medicine was elucidated from both its definition and conditions realized, and current status of drug development as well asopportunities and challenges we face under the new era of personalized medicine were briefly analyzed. In the meantime, current status and problemsto be solved in China were also analyzed to provide the reference for new drug development and personalized medicine in the future.
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