Quantitative signal detection using spontaneous ADR reporting
Quantitative methods are increasingly used to analyse spontaneous reports. We describe
the core concepts behind the most common methods, the proportional reporting ratio (PRR) …
the core concepts behind the most common methods, the proportional reporting ratio (PRR) …
Decision support methods for the detection of adverse events in post-marketing data
M Hauben, A Bate - Drug discovery today, 2009 - Elsevier
Spontaneous reporting is a crucial component of post-marketing drug safety surveillance
despite its significant limitations. The size and complexity of some spontaneous reporting …
despite its significant limitations. The size and complexity of some spontaneous reporting …
Data-driven prediction of drug effects and interactions
Adverse drug events remain a leading cause of morbidity and mortality around the world.
Many adverse events are not detected during clinical trials before a drug receives approval …
Many adverse events are not detected during clinical trials before a drug receives approval …
Performance of pharmacovigilance signal‐detection algorithms for the FDA adverse event reporting system
Signal‐detection algorithms (SDAs) are recognized as vital tools in pharmacovigilance.
However, their performance characteristics are generally unknown. By leveraging a unique …
However, their performance characteristics are generally unknown. By leveraging a unique …
Disproportionality analysis for pharmacovigilance signal detection in small databases or subsets: recommendations for limiting false-positive associations
O Caster, Y Aoki, LM Gattepaille, B Grundmark - Drug Safety, 2020 - Springer
Introduction Uncovering safety signals through the collection and assessment of individual
case reports remains a core pharmacovigilance activity. Despite the widespread use of …
case reports remains a core pharmacovigilance activity. Despite the widespread use of …
Good signal detection practices: evidence from IMI PROTECT
Over a period of 5 years, the Innovative Medicines Initiative PROTECT (
Pharmacoepidemiological Research on Outcomes of Therapeutics by a European …
Pharmacoepidemiological Research on Outcomes of Therapeutics by a European …
Antimicrobials and the risk of torsades de pointes: the contribution from data mining of the US FDA Adverse Event Reporting System
E Poluzzi, E Raschi, D Motola, U Moretti, F De Ponti - Drug safety, 2010 - Springer
Background: Drug-induced torsades de pointes (TdP) is a complex regulatory and clinical
problem due to the rarity of this sometimes fatal adverse event. In this context, the US FDA …
problem due to the rarity of this sometimes fatal adverse event. In this context, the US FDA …
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 …
disproportionality analysis (DA) represents a recognized approach for early signal detection …
[HTML][HTML] Mining association patterns of drug-interactions using post marketing FDA's spontaneous reporting data
Abstract Background and objectives Pharmacovigilance (PhV) is an important clinical
activity with strong implications for population health and clinical research. The main goal of …
activity with strong implications for population health and clinical research. The main goal of …
[HTML][HTML] Signal detection in pharmacovigilance: a review of informatics-driven approaches for the discovery of drug-drug interaction signals in different data sources
The objective of this article is to review the application of informatics-driven approaches in
the pharmacovigilance field with focus on drug-drug interaction (DDI) safety signal discovery …
the pharmacovigilance field with focus on drug-drug interaction (DDI) safety signal discovery …