Defining ‘Signal’ and its Subtypes in Pharmacovigilance Based on a Systematic Review of Previous Definitions

@article{Hauben2009DefiningA,
  title={Defining ‘Signal’ and its Subtypes in Pharmacovigilance Based on a Systematic Review of Previous Definitions},
  author={Manfred Hauben and Jeffrey K Aronson},
  journal={Drug Safety},
  year={2009},
  volume={32},
  pages={99-110}
}
Having surveyed the etymology and previous definitions of the pharmacovigilanceterm ‘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 syndrome… CONTINUE READING
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