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2017 年 1 月美国和欧盟新批准药物概述
引用本文:孙友松.2017 年 1 月美国和欧盟新批准药物概述[J].微生物学杂志,2017(2).
作者姓名:孙友松
摘    要:2017 年 1 月,美国和欧盟共批准 20 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。

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 and EU in January 2017
SUN Yousong.An Overview of New Drugs Approved in the US and EU in January 2017[J].Journal of Microbiology,2017(2).
Authors:SUN Yousong
Abstract:In January 2017, US Food and Drug Administration (FDA) and European Commission had totally approved 20 new drugs, including new molecular entities, new active ingredients, new biologics and new line extensions (new indications and new formulations). In this article, new molecular entities, new active ingredients and new biologics receiving their rst global approval were analyzed with emphasis on the outcomes of clinical trials and development histories.
Keywords:drug approval  clinical trial  new molecular entity  new biologics
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