Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems

Spontaneous reporting systems remain pivotal for post-marketing surveillance and disproportionality analysis (DA) represents a recognized approach for early signal detection. Although DAs cannot be used per se as a standalone approach to assess a drug-related risk and cannot replace clinical judgmen...

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Main Authors: Paola Maria Cutroneo, Daniele Sartori, Marco Tuccori, Salvatore Crisafulli, Vera Battini, Carla Carnovale, Concetta Rafaniello, Annalisa Capuano, Elisabetta Poluzzi, Ugo Moretti, Emanuel Raschi
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-01-01
Series:Frontiers in Drug Safety and Regulation
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1323057/full