A concept for causality assessment and causal inference of adverse events cases

Submitted: August 3, 2022
Accepted: October 19, 2022
Published: November 2, 2022
Abstract Views: 820
PDF: 337
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Dear Editor,

 

Causality assessment of adverse drug events is essential in pharmacovigilance to assess the relationship between the medicine and the event.1,2 Regulatory authorities recommend using standardized methods for causality assessment.3,4 The World Health Organization-Uppsala Monitoring Center (WHO-UMC) system offers generalized criteria for establishing causal relationships.3 In contrast, the Roussel Uclaf Causality Assessment Method (RUCAM) provides a specialized system to assess Drug-Induced Liver Injury (DILI) cases. We systematically reviewed the literature and verified that these systems are among the best tools currently available for signal detection and causality assessment. [...]

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Citations

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How to Cite

Al-Imam, A., Sami, A., Lane, S., & Younus, M. (2022). A concept for causality assessment and causal inference of adverse events cases. Journal of Biological Research - Bollettino Della Società Italiana Di Biologia Sperimentale, 95(2). https://doi.org/10.4081/jbr.2022.10772