美国获批儿科药物及其在我国的研发现状

发布时间：2018-09-04 11:54

【摘要】：儿科用药缺乏一直是世界性难题,究其原因,主要在于其临床试验难度大以及儿童专用剂型、儿童用药规格和儿科临床用药信息的缺乏。然而,在美国,有关儿童用药法规相对健全,且已有多个儿科药物获得FDA批准。概述并解析1996—2016年美国FDA批准的儿科药物以及这些药物在我国的上市和申报状况。
[Abstract]:Paediatric drug shortage has been a worldwide problem, which is mainly due to the difficulty of clinical trials and the lack of special dosage forms for children, drug specifications for children and information on clinical use in pediatrics. However, in the United States, child drug use laws are relatively sound, and many paediatric drugs have been approved by the FDA. The paediatric drugs approved by FDA from 1996 to 2016 and their marketing and declaration in China are summarized and analyzed.
【作者单位】： 杭州咸达医药科技有限公司;
【分类号】：R985
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本文编号：2222026