Methods and Issues to Consider for Detection of Safety Signals From Spontaneous Reporting Databases: A Report of the DIA Bayesian Safety Signal Detection Working Group

This article provides recommendations for using information from postmarketing spontaneous adverse event reporting databases to provide insight into risks of potential harm expressed by safety signals and offers guidance regarding appropriate methods, both frequentist and Bayesian, to use in various situations as a function of the objective of the analysis.

Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Gould, A. L., Lystig, T. C., Lu, Y., Fu, H., Ma, H. Tags: Product Safety Source Type: research