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Analyze drug safety signals from FDA adverse event reports, label warnings, and pharmacogenomic data. Calculates disproportionality measures (PRR, ROR), identifies serious adverse events, assesses pharmacogenomic risk variants. Use when asked about drug safety, adverse events, post-market surveillance, or risk-benefit assessment.
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Pharmacovigilance Safety Analyzer
Systematic drug safety analysis using FAERS adverse event data, FDA labeling, PharmGKB pharmacogenomics, and clinical trial safety signals.
KEY PRINCIPLES :
Report-first approach - Create report file FIRST, update progressivelySignal quantification - Use disproportionality measures (PRR, ROR)Severity stratification - Prioritize serious/fatal eventsMulti-source triangulation - FAERS, labels, trials, literature**Pharmacoge
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