openalexZenodo (CERN European Organization for Nuclear Research)2026-07-26
Leakage-Controlled Seriousness Triage of FAERS Reports: A Temporal Validation Framework with LLM Comparison on Novel First-in-Class Drugs
Background. Post-marketing pharmacovigilance depends on the timely identification of serious individual case safety reports (ICSRs) from large spontaneous-reporting databases such as the FDA Adverse Event Reporting System (FAERS). Machine-learning triage has been proposed to prio…