An Experimental Investigation of Masking in the US FDA Adverse Event Reporting System Database

被引：0
|
作者：
Hsin-wei Wang
Alan M. Hochberg
Ronald K. Pearson
Manfred Hauben
机构：
[1] Computational Sciences Centre of Emphasis,Risk Management Strategy
[2] Pfizer Global Research and Development,undefined
[3] ProSanos Corporation,undefined
[4] Pfizer Inc.,undefined
[5] New York University School of Medicine,undefined
[6] New York Medical College,undefined
[7] Brunel University,undefined
来源：
Drug Safety | 2010年 / 33卷
关键词：
Adverse Event Reporting System; Spontaneous Reporting System; Drug Removal; Pharmaceutical Company Database; Disproportionality Analysis;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Background: A phenomenon of ‘masking’ or ‘cloaking’ in pharmacovigilance data mining has been described, which can potentially cause signals of disproportionate reporting (SDRs) to be missed, particularly in pharmaceutical company databases. Masking has been predicted theoretically, observed anecdotally or studied to a limited extent in both pharmaceutical company and health authority databases, but no previous publication systematically assesses its occurrence in a large health authority database.
引用
收藏
页码：1117 / 1133
页数：16
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