Claude Skills by malekokour

The method, published. If you want to extend this library — or build a different one on the same discipline — this is what a package owes and how it earns its status. Nothing here is proprietary. The reason it is public is that one person cannot author a profession's worth of workflows, and a contribution path without a stated standard produces contributions nobody can accept.

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 unstated, or stated inconsistently across documents. Use this skill when someone asks whether demographic covariates are adequately characterised for a programme, whether the age...

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 evidence a programme is still missing, whether a plan covers what a reviewer will expect, or which studies the drug's own properties have made obligatory — for example "what CP w...

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 and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of model evaluation and diagnostics; approve ...

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 ...

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 population modelling and not for non-compartmental parameters - names objectives that become unanswerable rather than letting them surface at reporting, and builds the propagation list fr...

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 guidance-anchored criteria that create study or analysis obligations for each population. Use this skill when someone asks whether the special-population strategy covers what a reviewer will ex...

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 against the cited evidence and no position reads as agreed or accepted. Use this skill when someone asks to draft or review applicant's positions for a regulatory interaction, stress-t...

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 interviewed; mentions a work profile, professional constitution, project instructions, reusable context, Copilot or ChatGPT context, or wants to combine an existing context file with new...

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 made until the regulatory owner confirms it. Use this skill when someone asks to capture minutes from a regulatory meeting, extract commitments from meeting notes, structure the ...

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 PK-section completeness and version reconciliation. Example: \"Please a clinical pharmacologist and medical or regulatory reviewer need a source-located IB PK-section completeness and ve...

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 knowledge assets and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of sops, templates and knowledge a...

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 data cut-off as separate fields, and traces every fact in the stated basis back to the pack the committee actually saw so knowledge drawn from outside the record is flagged rather...

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: \"Please a clinical pharmacologist or regulatory reviewer needs a source-located IND/CTA/IMPD content inventory.\" Do not use it to decide trial-phase adequacy, filing readiness...

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, narrows by job-tree nav_path, then returns top-1 with reasons, asks the user, or refuses human-only/OOS/safety work. Example: \"Which skill should handle reviewing this bioanalytic...

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 asks to break down, triage, map, track or check coverage of an agency question, information request, list of questions, request for supplementary information or meeting-minute act...

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 denominators of parameters, subjects and pipeline stages covered, and flags discrepancies resolved by the primary analyst alone, which returns the deliverable to single control exac...

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 clinical or regulatory decision. Use when asked to prepare or review an assessment aid's CP section. Do not use for drafting agency responses, for meeting preparation, or for taking a ...

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 draft, structure, stress-test or QC the CP content of a briefing book or meeting package — for example "draft the clin pharm section of our pre-NDA briefing package", "which questio...

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 carrying a locator and every gap named. Use this skill when someone asks to assemble, index, organise or gap-check the evidence supporting a proposed dose or regimen — for example "pull...

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 sample size, states the implication for the next dose level rather than leaving the committee to extrapolate from the current one, and makes what the pack cannot show a named sect...

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 meeting. Do not use for drafting label text, for taking a negotiating position, or for predicting what an agency will accept.

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 when preparing or reviewing the CP contribution to a meeting request. Do not use for drafting the meeting request itself, for rehearsal coaching, or for taking a negotiating position.

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 informs — structured so that every element traces to its source and no model-derived conclusion is stated as a fact. Use this skill when someone asks to assemble or review a MID...

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 agency discussion. Do not use for drafting the position itself, for deciding the position, or for predicting what an agency will accept.

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 those cases are usually the sickest, reports stratum event counts before any rate because a rising percentage across two three and four events is not a relationship, and reports the...

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 over time, asks where a changed value propagates, or traces declared PD/biomarker fields, synthetic privacy structures, ethics records, or topline facts across a programme. Exam...

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 reporting dates are covered, whether successive periodic reports leave a gap, or where a DSUR and an IND annual report cover the same dates. Example: \"Please a regulatory or saf...

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 the CCDS, RSI and regional-label safety lists and preserve every divergence with locators.\" Do not use to decide whether a discrepancy requires a local label or RSI change, au...

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 characterisation plan or results for an ADC or other multi-analyte modality — for example "does this analyte set support a DAR-shift question" or "check that total antibody and c...

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 produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of adme and routes of elimination; approve or submit...

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 \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of agent-based models; approve or submit related documents; select or adjust a dose; spe...

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 finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of ai/ml workflow automation; approve or submit related documents; ...

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 standards and provenance and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of analysis dataset...

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 science contribution and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of applied regulatory sci...

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 against predicted terminal concentrations rather than peak, checks long-term stability against the interval to the last analysis rather than the first, and flags points where the...

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 bioanalytical report covers what the standard requires, or whether its stated stability, dilution, carryover and reanalysis content supports the PK data drawn from it — for example "check t...

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 materials for Bioequivalence statistics - TOST and confidence intervals and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do n...

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 finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of biomarker fit-for-purpose; approve or submit related documents; ...

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 target-engagement strategy and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of biomarker and targe...

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 Biopharmaceutics, BA/BE and formulation bridging and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcom...

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 produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of biosimilar and generic defence; approve or submit...

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 bioanalytical report, requires sampling and dosing deviations to be handled by distinct rules, classifies each exclusion by whether it can be applied without seeing the result, and reconci...

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 (PC, PP) and define.xml and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of cdisc pk domains (p...

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 classifies it against magnitude bands transcribed from the guidance in force, and separates inconclusive studies from negative ones. Use it to review a dedicated interaction stu...

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 meaningfulness of covariate effects and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of clinica...

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 sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of cmc change ba/be assessment; approve or submit related doc...

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 content differences between CCDS and regional labels are documented rather than silent. Use when reviewing a CCDS draft. Do not use for regional label review or for deciding what co...

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 register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of competitive landscape; approve or submit related documents; select or adjust...

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 Computational environment and reproducibility and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of comp...