https://doi.org/10.4081/jbr.2022.10772

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

Vol. 95 No. 2 (2022)
Submitted: August 3, 2022
Accepted: October 19, 2022
Published: November 2, 2022
Chemical and drug-induced liver injury, pharmacovigilance, RUCAM system, signal Detection, WHO-UMC causality assessment system
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Authors

Ahmed Al-Imam
ahmed.mohammed@comed.uobaghdad.edu.iq
https://orcid.org/0000-0003-1846-9424
Department of Anatomy and Cellular Biology, College of Medicine, University of Baghdad, Baghdad, Iraq; Department of Computer Science and Statistics, Doctoral School, Poznan University of Medical Sciences, Poznan, Poland; Alumni Ambassador, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.
Ahmed Sami
College of Pharmacy, Al-Mustansiriya University, Baghdad, Iraq; Baghdad Teaching Hospital, Baghdad Medical City Teaching Complex, Baghdad, Iraq.
Samantha Lane
Drug Safety Research Unit, Southampton, United Kingdom.
Manal Younus
Iraqi Pharmacovigilance Centre, Ministry of Health, Baghdad, Iraq; International Society of Pharmacovigilance, Middle East Chapter, London, United Kingdom.

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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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
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