Limitations and strengths of spontaneous reports data

被引：176
作者：
Goldman, SA [1 ]
机构：
[1] US FDA, Off Commissioner, Rockville, MD 20857 USA
来源：
CLINICAL THERAPEUTICS | 1998年 / 20卷
关键词：
FDA; spontaneous reports; postmarketing surveillance; adverse drug event;
D O I：
10.1016/S0149-2918(98)80007-6
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
US Food and Drug Administration (FDA) monitoring of the continued safety of marketed medical products depends greatly on spontaneous reporting of serious adverse events by health professionals. Despite its inherent limitations, the national postmarketing surveillance system provides vital information of clinical importance.
引用
收藏
页码：C40 / C44
页数：5
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