When serious adverse drug events (ADEs) are reported to a pharmaceutical company and the etiology is unclear, a consultant may be called upon to interpret the signal. These suspected adverse drug reactions are frequently complex cases with multiple possible drug etiologies and underlying disease states. The role of a consultant in dealing with these problems includes assessing the quality of the information, choosing a methodology for making a causality assessment, and making recommendations regarding the course of action to take with the drug. In this manuscript, we describe a Bayesian method for ADE assessment and its use in the safety evaluation of pharmaceuticals.
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