The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplete and ambiguous reporting, and carries the risk of incorrect...

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Main Authors: Fusaroli, M, Salvo, F, Begaud, B, AlShammari, TM, Bate, A, Battini, V, Brueckner, A, Candore, G, Carnovale, C, Crisafulli, S, Cutroneo, PM, Dolladille, C, Drici, M, Faillie, J, Goldman, A, Hauben, M, Herdeiro, MT, Mahaux, O, Manlik, K, Montastruc, F, Noguchi, Y, Norén, GN, Noseda, R, Onakpoya, IJ, Sartori, D
Format: Journal article
Language:English
Published: Springer 2024