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Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions.

Abstract:

Having surveyed the etymology and previous definitions of the pharmacovigilance term 'signal', we propose a definition that embraces all the surveyed ideas, reflects real-world pharmacovigilance processes, and accommodates signals of both harmful and beneficial effects. The essential definitional features of a pharmacovigilance signal are (i) that it is based on one or more reports of an association between an intervention or interventions and an event or set of related events (e.g. a syndrom...

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Publication status:
Published

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Institution:
University of Oxford
Department:
Oxford, MSD, Primary Care Health Sciences, PHC-Seniors
Journal:
Drug safety
Volume:
32
Issue:
2
Pages:
99-110
Publication date:
2009
DOI:
ISSN:
0114-5916
URN:
uuid:25098228-fe7d-4422-8f48-b0faddfbe967
Source identifiers:
117095
Local pid:
pubs:117095

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