domains / families / science / faers-pharmacovigilance-disproportionality-research-planner

faers-pharmacovigilance-disproportionality-research-planner

separate

Generates complete FAERS-style pharmacovigilance disproportionality research designs from a user-provided drug class, comparator strategy, adverse-event domain, and patient-group stratification. Always use this skill whenever a user wants to design, plan, or build a spontaneous-report safety signal study using FAERS or a similar pharmacovigilance database, especially when the article logic includes product selection, indication-group stratification, MedDRA-based adverse-event extraction, serious-case filtering, suspect-drug and concomitant-exclusion logic, reporting odds ratio analysis, comparator-drug benchmarking, cross-drug comparison, and cautious signal interpretation without causal overclaiming. Covers five study patterns (single-drug disproportionality workflow, multi-drug class comparison workflow, indication-stratified workflow, comparator-controlled signal screening workflow...

When to use

• design spontaneous-report safety signal study
• plan FAERS disproportionality analysis
• build pharmacovigilance study plan
• product selection and indication-group stratification
• MedDRA-based adverse-event extraction
• serious-case filtering and suspect-drug logic
• reporting odds ratio analysis
• comparator-drug benchmarking and cross-drug comparison

When not to use

• clinical treatment recommendations
• prescribing changes
• patient-specific diagnosis
• randomized trials
• cohort effectiveness studies
• mechanistic wet-lab studies
• pure EHR claims studies without spontaneous-report disproportionality design
• non-biomedical or off-topic requests

Skill page

Source