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Pharmacovigilance, Signal Detection and Signal ...(药物警戒,信号检测和信号)
14th International Conference on Information Fusion
Chicago, Illinois, USA, July 5-8, 2011
Pharmacovigilance, Signal Detection and Signal
Intelligence Overview
Atsuko Shibata Manfred Hauben
Global Safety Risk Management Strategy
Amgen Inc. Pfizer Inc.
Thousand Oaks, CA, U.S.A. New York, NY, U.S.A.
ashibata@ Manfred.Hauben@P
Abstract - The field of pharmacovigilance (or drug patient populations that may be exposed to the drug once
safety surveillance) has evolved significantly over the on the market), the limited duration of exposure to the drug
last few years. Most notably, various statistical methods per study subject (particularly in the case of a drug
have been developed and applied to the scan of large- intended for long-term use), limited or no data for
scale adverse event (AE) databases to identify potentially higher-risk patient sub-populations that are
disproportionality in the reporting of specific product- often excluded from controlled clinical trials (e.g., patients
AE combinations against marginal distributions as a with organ impairment, pediatric and geriatric patients, and
background. This paper provides an overview of the women of childbeari
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