2014年美国FDA批准上市新药回顾及重点药物分析

Chinese Journal of New Drugs(2015)

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Abstract
从技术创新和审评方式的角度,介绍了2014年FDA批准上市新药的总体情况.对药物研发市场的热点治疗领域(肿瘤、代谢疾病、感染性疾病等)及其罕见病领域的重点药物,从作用机制角度逐一进行介绍和评述,并就新药研发的现状与趋势进行分析.
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Key words
new drugs coming into the market,2014,new chemical entity,biologics,breakthrough therapy designation,antitumor agent,metabolic diseases,rare disease
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