FDA pharmaceutical quality oversight.

导出 LinkOut

翻译打印收藏纠错

作者： Lawrence X,Yu ^[1] ; Janet,Woodcock ^[2]

作者单位： Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: lawrence.yu@fda.hhs.gov. ^[1] Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. ^[2]

关键词 Facility investigations Integrated quality assessment Pharmaceutical quality Pharmaceutical surveillance Quality by design Quality manufacturing systems

主题词制药工业(Drug Industry);药物, 通用名(Drugs, Generic);人类(Humans);工艺学, 制药(Technology, Pharmaceutical);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1016/j.ijpharm.2015.05.066

PMID 26027494

发布时间 2015-08-05

翻译满意度评价：

准确一般字义偏差语意偏离译文作用小提交