Exploring the impact of co-exposure timing on drug-drug interactions in signal detection through spontaneous reporting system databases: a scoping review
M Cocco, C Carnovale, E Clementi… - Expert Review of …, 2024 - Taylor & Francis
ABSTRACT Introduction Drug-drug interactions (DDIs) are defined as the pharmacological
effects produced by the concomitant administration of two or more drugs. To minimize false …
effects produced by the concomitant administration of two or more drugs. To minimize false …
The evolving role of disproportionality analysis in pharmacovigilance
M Fusaroli, E Raschi, E Poluzzi… - Expert Opinion on Drug …, 2024 - Taylor & Francis
Introduction From 2009 to 2015, the IMI PROTECT conducted rigorous studies addressing
questions about optimal implementation and significance of disproportionality analyses …
questions about optimal implementation and significance of disproportionality analyses …
The reporting of a disproportionality analysis for drug Safety signal detection using individual case safety reports in pharmacovigilance (READUS-PV): explanation …
In pharmacovigilance, disproportionality analyses based on individual case safety reports
are widely used to detect safety signals. Unfortunately, publishing disproportionality …
are widely used to detect safety signals. Unfortunately, publishing disproportionality …
Meta-analyzing results from disproportionality analysis of individual case safety reports: a note of caution
In a recent systematic review with meta-analysis, Williams et al summarized findings from 8
observational studies to estimate the risk of impulse control disorders (ICDs) associated with …
observational studies to estimate the risk of impulse control disorders (ICDs) associated with …
The real-world safety of oseltamivir and baloxavir marboxil in children: a disproportionality analysis of the FDA adverse event reporting system
W Wei, L Huang, Y Bai, E Chang, J Liu - Frontiers in Pharmacology, 2024 - frontiersin.org
Background Oseltamivir and baloxavir marboxil are the two primary oral drugs approved by
the Food and Drug Administration (FDA) for treating influenza. Limited real-world evidence …
the Food and Drug Administration (FDA) for treating influenza. Limited real-world evidence …
Safety of Dual Orexin Receptor Antagonist Daridorexant: A Disproportionality Analysis of Publicly Available FAERS Data
G Cicala, MA Barbieri, G Russo, F Salvo, E Spina - Pharmaceuticals, 2024 - mdpi.com
Daridorexant (dari), as the first dual orexin receptor antagonist (DORA) marketed in Europe,
offers a novel therapeutic approach to insomnia. However, data regarding its real-world …
offers a novel therapeutic approach to insomnia. However, data regarding its real-world …
Post-marketing safety concerns of sotorasib: A disproportionality analysis based on FDA adverse event reporting system
Y Ding, H Su, Y Shu, J Chen - Heliyon, 2024 - cell.com
Background Sotorasib has been approved for the treatment of adult patients with KRAS
G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Due to …
G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Due to …
Safety assessment of dapagliflozin: real-world adverse event analysis based on the FAERS database from 2012 to 2023
Z Zhou, X Yao - Heliyon, 2024 - cell.com
Background Dapagliflozin possesses the capacity to cure a wide range of diseases,
however, there are many adverse events (AEs) that have not yet been acknowledged or …
however, there are many adverse events (AEs) that have not yet been acknowledged or …
Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis
E Raschi, F Salvo, A Bate, F De Ponti, E Poluzzi… - Drug Safety, 2024 - Springer
The process of peer review represents the gold standard for evaluating medical science
across journals and disciplines and is considered a key pillar to ensure reliable research …
across journals and disciplines and is considered a key pillar to ensure reliable research …