malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Assembles the exposure content a safety or escalation committee decides from, derived from the governing rule rather than from whatever data happens to be available. It reports subjects dosed, evaluable, and with the parameter as three distinct denominators, presents every parameter with its precision at the current…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Structures the clinical pharmacology input to a labelling negotiation — assembling the evidence for each CP labelling position, mapping each position to its regulatory precedent, and identifying where the evidence supports the position and where it does not. Use when preparing for a labelling review or negotiation…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Structures the clinical pharmacology input to an agency meeting strategy — identifying which CP topics warrant discussion, mapping each to the available meeting types (Type A/B/C for FDA; scientific advice, protocol assistance for EMA), and building the briefing package that supports the requested meeting type. Use…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Assembles and reviews the clinical pharmacology content of a Model-Informed Drug Development (MIDD) regulatory engagement package — the modelling question, the model context of use, the qualification or fitness-for-purpose argument, the key assumptions with their sensitivity analyses, and the decision the model output…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Structures a clinical pharmacology position defence brief — the evidence-backed argument for a CP position the team expects to defend before an agency. Maps the position statement to its evidence chain, identifies vulnerabilities, and assembles counter-arguments with sourced data. Use when preparing a CP position for…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Prepares the exposure contribution to a safety signal review - whether an event tracks exposure, and what the available data could have shown either way. It justifies the exposure metric against the event mechanism rather than defaulting, counts affected subjects lacking PK data and states the bias direction since…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Maintains a register of clinical pharmacology values and claims across a programme's document thread — protocol, CSR, Module 2.7.2, briefing documents and label — and supports bounded privacy structure, ethics-submission, topline snapshot, and PD/biomarker context tracing. Use when a request spans documents or studies…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Compares declared reporting periods across Development Safety Update Reports (DSURs) and US IND annual reports, flagging calendar gaps, same-format overlaps, and potential cross-format duplicate coverage while preserving the source status of every period. Use this skill when a regulatory or safety reviewer asks which…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Compare supplied CCDS, CCSI, RSI, periodic-report, and regional-label reference safety lists and versioned change records, preserving list divergence with both locators. Use when a clinical pharmacologist or safety/labeling reviewer needs a mechanical reconciliation of reference safety information. Example: "Reconcile…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews the analyte strategy for an antibody-drug conjugate — which analytes are measured, how each is defined, whether the set supports the exposure questions the programme asks, and whether reported parameters are internally consistent across analytes. Use this skill when someone asks to review, QC, or check the PK…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews ADME and routes of elimination evidence pack for the L3 task «ADME and routes of elimination». 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 ADME and routes of elimination and…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Agent-based models evidence pack for the L3 task «Agent-based models». 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 Agent-based models and produce a sourced finding register…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews AI/ML workflow automation evidence pack for the L3 task «AI/ML workflow automation». 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 AI/ML workflow automation and produce a sourced…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Analysis dataset standards and provenance evidence pack for the L3 task «Analysis dataset standards and provenance». 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 Analysis dataset…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Applied regulatory science contribution evidence pack for the L3 task «Applied regulatory science contribution». 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 Applied regulatory…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews a bioanalytical plan before samples are collected - which analytes will be measured, in what matrix, over what calibration range, and whether that range covers the concentrations the study will actually produce. It derives required analytes from the objectives before reading the plan, compares the lower limit…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews the content of a bioanalytical method validation report and its study sample analysis report against the shared ICH M10 conformance rubric, producing an element-by-element conformance register plus the subset of observations that bear on PK interpretation. Use this skill when someone asks whether a…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Bioequivalence statistics - TOST and confidence intervals evidence pack for the L3 task «Bioequivalence statistics - TOST and confidence intervals». 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…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Biomarker fit-for-purpose evidence pack for the L3 task «Biomarker fit-for-purpose». 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 Biomarker fit-for-purpose and produce a sourced…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Biomarker and target-engagement strategy evidence pack for the L3 task «Biomarker and target-engagement strategy». 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 Biomarker and…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews Biopharmaceutics, BA/BE and formulation bridging evidence pack for the L3 task «Biopharmaceutics, BA/BE and formulation bridging». 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 Biosimilar and generic defence evidence pack for the L3 task «Biosimilar and generic defence». 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 Biosimilar and generic defence and…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews the data-handling rules that determine what an analysis dataset contains - BLQ method, actual-versus-nominal times, and exclusions. It records the censored proportion alongside the BLQ method because the choice only matters in proportion to it, checks the quantification limit in the plan against the…
malekokour/clinpharm-pmx-skills
Skill Claude CodeCodex
Reviews CDISC PK domains (PC, PP) and define.xml evidence pack for the L3 task «CDISC PK domains (PC, PP) and define.xml». 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 CDISC PK domains…