【摘要】：兒科用藥缺乏一直是世界性難題,究其原因,主要在于其臨床試驗難度大以及兒童專用劑型、兒童用藥規(guī)格和兒科臨床用藥信息的缺乏。然而,在美國,有關(guān)兒童用藥法規(guī)相對健全,且已有多個兒科藥物獲得FDA批準(zhǔn)。概述并解析1996—2016年美國FDA批準(zhǔn)的兒科藥物以及這些藥物在我國的上市和申報狀況。
[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.
【作者單位】： 杭州咸達醫(yī)藥科技有限公司;
【分類號】：R985
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本文編號：2222026