自发报告数据的局限性和优势。
Limitations and strengths of spontaneous reports data.
作者信息
Goldman S A
机构信息
Office of the Commissioner, US Food and Drug Administration, Rockville, Maryland 20857, USA.
出版信息
Clin Ther. 1998;20 Suppl C:C40-4. doi: 10.1016/s0149-2918(98)80007-6.
PMID:9915089
Abstract
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.
摘要
美国食品药品监督管理局（FDA）对已上市医疗产品持续安全性的监测在很大程度上依赖于医疗专业人员对严重不良事件的自发报告。尽管其存在固有局限性，但国家上市后监测系统提供了具有临床重要性的关键信息。
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