assess-pharmacogenomic-evidencelisted

Assesses whether pharmacogenomic covariate effects are characterised across the programme's evidence base — in-vitro enzyme and transporter genotype data, PopPK covariate analyses, dedicated PGx sub-studies, and the labelling concept — producing a gene-enzyme-phenotype register in which every stated PGx effect traces to its source and every source-identified polymorphism traces to its downstream statement. Use this skill when someone asks whether pharmacogenomic effects are characterised for a compound, whether a PopPK analysis covers the relevant polymorphisms, or what PGx gaps remain. Example: "Please pharmacogenomic effects are characterised for a compound." Do not use for demographic covariates (age, sex, body size), for organ-impairment characterisation, for drug-drug interaction assessment, or for any request to recommend a genotype-based dose adjustment.
malekokour/clinpharm-pmx-skills · ★ 6 · Code & Development · score 77

Install: claude install-skill malekokour/clinpharm-pmx-skills

# Pharmacogenomic Evidence Assessment Assess the characterisation of pharmacogenomic covariate effects across a programme's evidence base — in-vitro enzyme and transporter genotype data, population PK covariate analyses, dedicated PGx sub-studies, the FDA Table of Pharmacogenomic Biomarkers citations, and the labelling concept — producing a gene-enzyme-phenotype register in which every stated PGx effect traces to its analysis and every identified polymorphism traces to its downstream statement. **This skill assesses PGx characterisation completeness and traceability. It never recommends a genotype-based dose adjustment, decides whether a polymorphism warrants a label statement, or determines that PGx characterisation is sufficient for filing.** ## Who this is for Clinical pharmacology leads assessing whether pharmacogenomic effects are characterised before a submission · CP reviewers checking that every PGx statement in the label traces to the programme's own data · regulatory writers who need each pharmacogenomic claim source-linked. ## When to use this skill - "Are pharmacogenomic effects characterised for this compound?" - "Which CYP polymorphisms are covered in our PopPK and which are not?" - "Does the Section 12 PGx statement match the PopPK covariate analysis?" - "What PGx gaps remain before filing?" - "Reconcile the pharmacogenomic statements across the PopPK, 2.7.2 and label" ## When NOT to use this skill | Request | Why not this skill | Where it belongs | |--