malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews clinical drug-interaction study reports for design adequacy, result integrity and coverage against in-vitro triggers. It records the mechanism and index drug and flags mismatches, assesses whether the design could detect the effect it sought, extracts every geometric mean ratio with its confidence interval and…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Clinical meaningfulness of covariate effects evidence pack for the L3 task «Clinical meaningfulness of covariate effects». Produces a source-linked finding register with denominators and an explicit refuse list. Use when a practitioner asks to work this topic — e.g. "Please review the materials for Clinical…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews CMC change BA/BE assessment evidence pack for the L3 task «CMC change BA/BE assessment». Produces a source-linked finding register with denominators and an explicit refuse list. Use when a practitioner asks to work this topic — e.g. "Please review the materials for CMC change BA/BE assessment and produce a…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews the clinical pharmacology content of a Company Core Data Sheet (CCDS) — the sponsor's internal reference document that anchors all regional label variants. Checks that CP content is consistent with the authoritative evidence base, that it can support downstream regional labels (USPI, SmPC, JP PI), and that…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Competitive landscape evidence pack for the L3 task «Competitive landscape». Produces a source-linked finding register with denominators and an explicit refuse list. Use when a practitioner asks to work this topic — e.g. "Please review the materials for Competitive landscape and produce a sourced finding…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Computational environment and reproducibility evidence pack for the L3 task «Computational environment and reproducibility». Produces a source-linked finding register with denominators and an explicit refuse list. Use when a practitioner asks to work this topic — e.g. "Please review the materials for…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Consent for PK and genetic sampling evidence pack for the L3 task «Consent for PK and genetic sampling». Produces a source-linked finding register with denominators and an explicit refuse list. Use when a practitioner asks to work this topic — e.g. "Please review the materials for Consent for PK and genetic…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews CRO and vendor qualification and oversight evidence pack for the L3 task «CRO and vendor qualification and oversight». Produces a source-linked finding register with denominators and an explicit refuse list. Use when a practitioner asks to work this topic — e.g. "Please review the materials for CRO and vendor…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews the pharmacokinetic content of a draft clinical study report against its own synopsis, tables, figures and permitted source outputs, with bounded CSR-local PD/biomarker context and topline snapshot routes, producing a source-linked discrepancy register and QC memo. Use when someone asks to check or reconcile…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews the clinical pharmacology content of a CTD Module 2.5 Clinical Overview — the integrated narrative that places pharmacokinetic, pharmacodynamic, dose-selection, DDI, and special-population evidence into the benefit-risk context. Checks that every quantitative claim traces to a source in Modules 2.7.1-2.7.4 or…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews a CTD Module 2.7.1 Summary of Biopharmaceutics Studies against ICH M4E structure requirements and the underlying study reports. Checks that every biopharmaceutics study cited in the summary is present and traceable, that formulation chronology is stated, that the BCS class justification is sourced, and that…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews CTD Module 2.7.6 individual study synopses for completeness against their parent study reports and consistency with Module 2.7.1-2.7.4 summaries. Checks that every study in the clinical development programme has a synopsis, that each synopsis carries the ICH E3-mandated elements, and that key parameter values…