华山海拔多少米Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999期刊名称： Pharmacoepidemiol Drug Saf
作者： James Cross,Howard Lee,Agnes Westelinck,Julie Nelson,Carl Peck个人简历怎样写
葱油芋头年份： 2002年
期号： 第6期
关键词： drug dosage; label changes; postmarketing changes; dosage changes;
干橹new molecular entity
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浅若夏沫什么意思摘要：PURPOSE: Risks and benefits of marketed drugs can be improved by changing their labels to optimize dosage regimens for indicated populations. Such postmarketing label changes may reflect the quality of pre-marketing development, regulatory review, and postmarketing surveillance. We documented dosage changes of FDA-approved new molecular entities (NMEs), and investigated trends over time and across therapeutic groups, on the premi that improved drug development me
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thods have yielded fewer postmarketing label changes over time. METHODS: We compiled a list of NMEs approved by FDA from 1 January 1980 to 31 December 1999 using FDA's website, Freedom of Information Act request, and PhRMA (Pharmaceutical Rearch and Manufacturers of America) databa. Original labeled dosages and indicated patient populations were tracked in labels
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