Active Comparator Single-SOC FAERS Safety Comparison Planner

Problem

FAERS comparative safety studies can become vague when the drug class, comparator logic, safety domain, disproportionality analysis, and subgroup boundaries are not constrained. This skill is limited to a [drug class or comparator drugs] + [one predefined safety domain] input and produces an executable comparative FAERS safety study design, not a literature review or tool list.

How It Works

• Study inference: identifies the comparator set, safety domain, target level, and constraints; states assumptions when input is incomplete.
• Pattern selection: chooses among active-comparator disproportionality, single-SOC class comparison, within-class pharmacologic contrast, predefined PT panel, or subgroup-enhanced comparison.
• Four configurations: outputs Lite, Standard, Advanced, and Publication+, then recommends one primary path.
• Dependency check: verifies declared comparator restrictions, subgroup fields, onset fields, and evidence layers before allowing downstream steps.
• Reference layer: includes only verified DOI or stable-link references; marks evidence gaps instead of inventing PMID, DOI, authors, titles, or URLs.

Boundaries

It is for pharmacovigilance research design, not dosing, prescribing, patient-specific treatment decisions, pure EHR or claims studies, or mechanistic toxicology without a FAERS backbone. Causal or regulatory claims must remain separated from signal detection, comparator analysis, and subgroup characterization.