| 2016 年5 月美国、欧盟和日本新批准药物概述 |
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| 引用本文： | 孙友松. 2016 年5 月美国、欧盟和日本新批准药物概述[J]. 微生物学杂志, 2016, 0(6) |
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| 作者姓名： | 孙友松 |
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| 摘 要： | 2016 年5 月，美国、欧盟和日本共批准32 个新药，包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析，重点介绍这些药物的临床研究结果和研发历史进程。
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| 关 键 词： | 新药批准；临床试验；新分子实体；新生物制品 |
An Overview of New Drugs Approved in the US, EUand Japan in May 2016 |
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| SUN Yousong. An Overview of New Drugs Approved in the US, EUand Japan in May 2016[J]. Journal of Microbiology, 2016, 0(6) |
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| Authors: | SUN Yousong |
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| Abstract: | In May 2016, the total number of new drugs approved by US Food and Drug Administration (FDA), European Commission, and JapaneseMinistry of Health, Labour and Welfare (MHLW ) reached 32, including new molecular entities, new active ingredient, new biologics and new lineextensions (new indications and new formulations). In this article, new molecular entities, new active ingredients and new biologics receiving their firstglobal approval were analyzed with emphasis on the outcomes of clinical trials and development histories. |
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| Keywords: | drug approval clinical trial new molecular entity new biologics |
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