Claude Skills by malekokour

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 sampling and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of consent for pk and genetic samplin...

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 qualification and oversight and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of cro and vendo...

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 one CSR against its own NCA, statistical, protocol, SAP, PD/biomarker, or locked topline sources. Route multi-document or programme-thread work to reconcile-cross-document-facts. ...

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 5, that the dose rationale is stated and sourced, and that the overview does not contradict its summaries. Use when asked to review or gap-check a 2.5 draft's CP content. Do not ...

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 dissolution-PK links are consistent. Use when asked to review, QC, or gap-check a 2.7.1 draft before filing. Do not use for the biopharmaceutics content inside a CSR, for BA/BE stu...

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 agree with the full report. Use when asked to QC synopses before filing. Do not use for full CSR review, for Module 5 placement, or to decide which studies to include.

Reviews a draft Module 2.7.2 Summary of Clinical Pharmacology Studies against the fixed five-part ICH M4E(R2) structure, reconciles its dose content with Modules 2.7.3 and 2.7.4, and validates the Module 5 placement of every study it summarises. Use this skill when someone asks to review, QC, structure-check or reconcile a CTD 2.7.2 summary — for example "check our 2.7.2 against M4E before the dossier freeze" or "the dose in 2.7.2 and 2.7.4 do not match, find where". Do not use for reviewing ...

Reviews CTD 2.7.3.4 and 2.7.4 exposure-safety content against the analyses behind it. It traces every stated relationship to its analysis in both directions, so an omitted analysis is caught as well as an unsupported claim, treats a negative statement as a claim requiring evidence rather than an absence of one, and reports underpowered negatives separately from supported negatives because the two read identically and mean the opposite. It also checks exposure metric and analyte coherence agai...

Structures one compound's DDI package from in-vitro results, clinical studies, models, labels and literature under ICH M12 logic. It builds a source-linked enzyme/transporter inventory, assigns perpetrator/victim roles, carries each signal to an auditable terminus, and drafts management wording for review. Use it to assemble, review or gap-check DDI evidence, inventory enzyme/transporter characterization, check whether a clinical interaction study is triggered, or draft report, summary or lab...

Reviews Decision packages and go/no-go input evidence pack for the L3 task «Decision packages and go/no-go input». 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 Decision packages and go/no-go input and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of decision packages and go/no-go ...

Reviews Dialysis and organ replacement evidence pack for the L3 task «Dialysis and organ replacement». 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 Dialysis and organ replacement and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of dialysis and organ replacement; approve or submit...

Reviews Disease-progression modelling evidence pack for the L3 task «Disease-progression modelling». 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 Disease-progression modelling and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of disease-progression modelling; approve or submit rel...

Reviews a proposed dose-modification scheme — every rule's trigger, threshold, direction, and cited evidence — checking that each rule traces to an analysis, that the threshold matches its source, that the direction is consistent with the exposure change, and that the rule set is internally consistent and covers the populations the labelling concept names. Use this skill when someone asks to review dose-modification rules, check whether each rule is evidence-backed, reconcile modification thr...

Reviews Dose optimisation for cost and access evidence pack for the L3 task «Dose optimisation for cost and access». 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 Dose optimisation for cost and access and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of dose optimisation for cost a...

Reviews Dose proportionality, accumulation, time dependency evidence pack for the L3 task «Dose proportionality, accumulation, time dependency». 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 Dose proportionality, accumulation, time dependency and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide t...

Reviews Dose-ranging design input evidence pack for the L3 task «Dose-ranging design input». 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 Dose-ranging design input and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of dose-ranging design input; approve or submit related documents; ...

Reviews Drug utilisation and outcomes evidence pack for the L3 task «Drug utilisation and outcomes». 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 Drug utilisation and outcomes and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of drug utilisation and outcomes; approve or submit rel...

Reviews Due diligence and in-licensing evidence pack for the L3 task «Due diligence and in-licensing». 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 Due diligence and in-licensing and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of due diligence and in-licensing; approve or submit...

Reviews For efficacy evidence pack for the L3 task «For efficacy». 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 For efficacy and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of for efficacy; approve or submit related documents; select or adjust a dose; speak for the sponsor to an...

Reviews the dose-escalation design of a first-in-human or early-phase study — increment sizes and what justifies them, sentinel and staggering arrangements against the mechanism's risk features, and whether stopping rules are specific enough to apply under pressure. It flags increments justified only by convention, levels whose predicted exposure passes the study's own exposure cap, and rules that require a judgment call rather than stating a trigger. Use it for an escalation schema in a prot...

Reviews Ethics-committee interaction on CP content evidence pack for the L3 task «Ethics-committee interaction on CP content». 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 Ethics-committee interaction on CP content and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of ethics-commit...

Reviews Ethnic sensitivity and ICH E5 bridging evidence pack for the L3 task «Ethnic sensitivity and ICH E5 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 Ethnic sensitivity and ICH E5 bridging and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of ethnic sensitivity and ic...

Reviews the clinical pharmacology content of a draft EU Summary of Product Characteristics — sections 4.2, 4.5, 5.2 and the quantitative statements in 4.4 — against the SmPC guideline's required content, the QRD template's section structure, and the source data each statement claims to rest on. Use this skill when someone asks to review, QC, check the structure of, or trace the numbers in draft SmPC clinical pharmacology content — for example "does 5.2 cover all the populations it needs to" o...

Reviews Exposure cap and stopping rules evidence pack for the L3 task «Exposure cap and stopping rules». 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 Exposure cap and stopping rules and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of exposure cap and stopping rules; approve or su...

Reviews Exposure-response modelling evidence pack for the L3 task «Exposure-response modelling». 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 Exposure-response modelling and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of exposure-response modelling; approve or submit related doc...

Reviews Exposure-response relationships evidence pack for the L3 task «Exposure-response relationships». 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 Exposure-response relationships and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of exposure-response relationships; approve or su...

Reviews stated exposure safety margins — the ratio between a nonclinical no-observed-adverse-effect exposure and a clinical exposure — for whether each margin's basis is stated, its two sides are comparable, and its arithmetic reconciles. Use this skill when someone asks to review, QC, or trace a safety margin, a DILI or organ-toxicity exposure margin, or an exposure-based safety statement — for example "check the hepatic margin in the IB against the tox report" or "does every stated margin s...

Reviews External scientific engagement evidence pack for the L3 task «External scientific engagement». 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 External scientific engagement and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of external scientific engagement; approve or submit...

Reviews an already-written first-in-human starting-dose rationale — the most-sensitive-species argument, the NOAEL to HED to MRSD conversion chain, the MABEL consideration where the mechanism indicates one, and the escalation and stopping-rule skeleton — and recomputes every arithmetic step with a printed audit trail. Use this skill when someone asks to check, QC, verify or review an existing FIH dose rationale, IB dose-justification section or protocol starting-dose narrative — for example "...

Reviews Fixed versus weight-based dosing evidence pack for the L3 task «Fixed versus weight-based dosing». 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 Fixed versus weight-based dosing and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of fixed versus weight-based dosing; approve o...

Reviews Food effect and gastric pH / acid-reducing agents evidence pack for the L3 task «Food effect and gastric pH / acid-reducing agents». 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 Food effect and gastric pH / acid-reducing agents and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the out...

Reviews Guidance surveillance and impact assessment evidence pack for the L3 task «Guidance surveillance and impact 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 Guidance surveillance and impact assessment and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of guidance s...

Reviews Hepatic impairment evidence pack for the L3 task «Hepatic impairment». 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 Hepatic impairment and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of hepatic impairment; approve or submit related documents; select or adjust a dose; spe...

Reviews HTA and payer exposure evidence evidence pack for the L3 task «HTA and payer exposure evidence». 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 HTA and payer exposure evidence and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of hta and payer exposure evidence; approve or su...

Reviews a human pharmacokinetic prediction deliverable — allometric scaling, in vitro to in vivo extrapolation, or a PBPK model report — against the inputs it declares, the assumptions it states, and the qualification evidence it claims. Use this skill when someone asks to review, QC, or check the basis of a predicted human PK parameter, a first-in-human exposure projection, an IVIVE clearance estimate, or a PBPK model report — for example "does this PBPK report support the exposure it predic...

Reviews Immunogenicity assays evidence pack for the L3 task «Immunogenicity assays». 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 Immunogenicity assays and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of immunogenicity assays; approve or submit related documents; select or adjust...

Reviews Immunogenicity impact on PK evidence pack for the L3 task «Immunogenicity impact on PK». 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 Immunogenicity impact on PK and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of immunogenicity impact on pk; approve or submit related doc...

Reviews an in-vitro drug-interaction package for completeness, internal consistency and decision-readiness. It inventories which enzymes and transporters were assessed and which were not, classifies every reported inhibition and induction parameter against thresholds transcribed from the guidance in force, sums fraction metabolised with an explicit unassigned remainder, and lists every signal above threshold that has no terminus. Use it to gap-check reaction phenotyping, transporter assessmen...

Reviews Infectious disease - PTA and MIC target attainment evidence pack for the L3 task «Infectious disease - PTA and MIC target attainment». 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 Infectious disease - PTA and MIC target attainment and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the ...

Reviews Inspection readiness and data integrity evidence pack for the L3 task «Inspection readiness and data integrity». 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 Inspection readiness and data integrity and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of inspection readiness a...

Assesses a proposed interim or blinded look at accumulating PK data - what the protocol permits, what looking costs, and what the data can currently support. It distinguishes blinded, partially unblinded and fully unblinded review rather than letting one phrase cover all three, names who becomes conflicted by seeing the data since a person who has seen unblinded exposure cannot afterwards make a blinded judgment about an exclusion or amendment, assesses de-blinding risk in looks described as ...

Reviews the clinical pharmacology content of a Japanese package insert — Sections 9 (Precautions Concerning Patients with Specific Backgrounds), 10 (Interactions), and 16 (Pharmacokinetics) — against PMDA conventions and source data. Checks that PK parameters in Section 16 trace to study reports, that interaction statements in Section 10 are sourced and classified by mechanism, and that Section 9 population precautions are consistent with the PK evidence. Use when asked to review JP PI CP con...

Reviews Label differentiation evidence pack for the L3 task «Label differentiation». 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 Label differentiation and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of label differentiation; approve or submit related documents; select or adjust...

Reviews Line extensions - routes, formulations, devices evidence pack for the L3 task «Line extensions - routes, formulations, devices». 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 Line extensions - routes, formulations, devices and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome o...

Reviews Living dose-rationale thread evidence pack for the L3 task «Living dose-rationale thread». 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 Living dose-rationale thread and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of living dose-rationale thread; approve or submit related...

Reviews LMIC dosing and access considerations evidence pack for the L3 task «LMIC dosing and access considerations». 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 LMIC dosing and access considerations and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of lmic dosing and access consi...

Reviews Metabolite profiling and MIST evidence pack for the L3 task «Metabolite profiling and MIST». 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 Metabolite profiling and MIST and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of metabolite profiling and mist; approve or submit rel...

Reviews MIDD plan and model inventory evidence pack for the L3 task «MIDD plan and model inventory». 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 MIDD plan and model inventory and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of midd plan and model inventory; approve or submit rel...

Reviews Modality applicability evidence pack for the L3 task «Modality applicability». 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 Modality applicability and produce a sourced finding register \\u2014 do not decide the clinical or regulatory outcome.\". Do not use to decide the outcome of modality applicability; approve or submit related documents; select or ad...

Reviews a model analysis plan or report — population PK, PBPK, exposure–response or another model-informed deliverable — against its own stated questions, assumptions, pre-stated evaluation criteria and presented evidence, using the shared review-rubric library. Use this skill when someone asks to review, QC or gap-check a modelling plan or modelling report for completeness, traceability and internal consistency — for example "does this popPK report answer the question it was commissioned for...