摘要：

Identification of previously unsuspected potential adverse reactions to medicinal products after product launch is an essential, core aim of pharmacovigilance. The quantity of data accruing after product approval means that quantitative approaches have a central role to play in enabling and facilitating the detection, interpretation, and follow up of safety signals. In this chapter we describe an overview of the use of different quantitative approaches in the identification of safety signals and give some thoughts on areas of future research. We discuss approaches for the analysis of spontaneous reports and for observational databases, focusing on recent developments and strengths and limitations of the various approaches.

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