4 Result(s)
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Article
Open AccessThe Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement
Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and resul...
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Article
Open AccessThe 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 guidelin...
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Article
Open AccessSupporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study
Individual case reports are the main asset in pharmacovigilance signal management. Signal validation is the first stage after signal detection and aims to determine if there is sufficient evidence to justify f...
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Article
Preventability of Adverse Drug Reactions Related to Antibiotics: An Assessment Based on Spontaneous Reporting System
Antibiotics are commonly used in both outpatient and inpatient settings and are responsible for the majority of adverse drug reaction (ADR) reports. We aimed to characterize spontaneously reported ADRs associa...
