malekokour

malekokour/clinpharm-pmx-skills

Plugin Claude Code

Portable Agent Skills for clinical pharmacologists and pharmacometricians.

malekokour/clinpharm-pmx-skills

Plugin Claude Code

Portable Agent Skills for clinical pharmacologists and pharmacometricians. Skills review, reconcile, and prepare evidence. They never select a dose, sign off, or submit.

malekokour/clinpharm-pmx-skills

Instructions file CodexOpenCode

Instructions for malekokour/clinpharm-pmx-skills, covering clinpharm pmx skills contributor contract, product, the claim this repository defends, where truth lives and public-data boundary.

malekokour/clinpharm-pmx-skills

Instructions file

Instructions for malekokour/clinpharm-pmx-skills, a project described as: Turn any AI agent into a clinical pharmacologist and pharmacometrician. It reviews, reconciles, and prepares evidence. It never selects a dose, signs off, or submits.

malekokour/clinpharm-pmx-skills

Instructions file Gemini CLI

Instructions for malekokour/clinpharm-pmx-skills, a project described as: Turn any AI agent into a clinical pharmacologist and pharmacometrician. It reviews, reconciles, and prepares evidence. It never selects a dose, signs off, or submits.

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Assesses whether age, sex and body-size covariate effects on exposure are characterised, internally consistent, and traceable to their sources — the PopPK covariate analysis, any dedicated sub-study, the factor-coverage matrix and the labelling concept — and flags effects that are stated without a source, sourced but…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Assesses a clinical pharmacology development plan against guidance-anchored evidence expectations, classifying every expected element as present, triggered, waivable-with-rationale, or a residual gap, each traced to the criterion that creates the obligation. Use this skill when someone asks what clinical pharmacology…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Assesses Model evaluation and diagnostics evidence pack for the L3 task «Model evaluation and diagnostics». 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 assess the materials for Model evaluation and diagnostics…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

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…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Assesses what a protocol amendment does to data a running study has already produced and to what the study can still conclude. It states enrolment at the time of amendment because impact scales with it, assesses poolability per analysis rather than once for the study - a sampling change is often poolable for…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Assesses the completeness and internal consistency of a programme's special-population evidence strategy — renal impairment, hepatic impairment, paediatrics, pregnancy and lactation, elderly, and other defined sub-populations — against the programme's declared scope, the target product profile, and the…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Drafts and reviews the clinical pharmacology applicant's-position sections of a regulatory briefing package — each position stated as a claim with its scope, the evidence that supports it, the pre-specified rule it rests on, its limitations, and its residual gaps — structured so that every position is auditable…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Builds, updates, refreshes, and exports portable work context for pharmaceutical and biotech professionals. Use this skill whenever someone wants AI to understand their pharma role, department, responsibilities, projects, sources, terminology, constraints, approval rules, or preferred deliverables; asks to be…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Captures structured minutes and commitment records from a regulatory interaction — each agenda item with its stated outcome, each commitment with its exact wording and owner, each open item with its trigger, and each factual statement with its locator — so that the record is auditable and no commitment is recorded as…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Check a supplied Investigator's Brochure for declared human pharmacokinetics/product-metabolism and related effects-in-humans content, then compare its version/date with a supplied DSUR citation register. Use this skill when a clinical pharmacologist and medical or regulatory reviewer need a source-located IB…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Curates SOPs, templates and knowledge assets evidence pack for the L3 task «SOPs, templates and knowledge assets». 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 curate the materials for SOPs, templates and…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Records or reviews a safety or escalation committee decision so it can be understood a year later or by an inspector. It requires the decision to name exactly one action and flags wording that permits more than one, verifies quorum against the charter rather than inferring it from attendance, keeps decision date and…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Locate and inventory clinical-pharmacology-relevant mechanism and ADME disclosures embedded in an IND pharmacology/drug-disposition section or the Module-4/5-shaped summaries of an IMPD. Use this skill when a clinical pharmacologist or regulatory reviewer needs a source-located IND/CTA/IMPD content inventory. Example…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Selects which ClinPharm PMx Skills skill to run for a user or agent request inside this repository. Use when the task is ambiguous across skills, the user asks which skill to use, routing or skill selection is needed, or the host should ask/refuse instead of guessing. Classifies SIMPLE / SINGLE / AMBIGUOUS / MULTI…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Triages a received health-authority information request into atomic answerable units and maps each unit to its source evidence, its gaps, and a proposed owner, with completeness reported as a fraction against both the request itself and the standard clinical pharmacology question battery. Use this skill when someone…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Establishes whether an NCA quality-control pass was structurally sound, rather than assuming it from the words dual control. It classifies independence on an explicit scale - same script rerun through to different software entirely - and records whether the checker saw the primary results first, expresses scope as…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Structures the clinical pharmacology content of an assessment aid or applicant's position document — the tabulated summary an agency requests to facilitate their review. Extracts every CP claim, traces it to its source document, verifies internal consistency, and flags any position statement that crosses into a…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Drafts and reviews the clinical pharmacology portion of a regulatory briefing package — answerable questions to the agency, applicant positions with their supporting evidence, and validated annex cross-references — aligned to the public structure of clinical pharmacology review. Use this skill when someone asks to…

malekokour/clinpharm-pmx-skills

Skill Claude CodeCodex

Assembles and organises the evidence behind a registration or dose-optimisation dose justification — exposure-response integration, intrinsic and extrinsic factor coverage, formulation-bridging logic, dose-modification rules — arranged against the questions clinical pharmacology reviewers ask, with every claim…