review-adc-analyte-strategy
SolidReviews 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 conjugated payload are consistently defined across these documents". Do not use to select an analyte strategy, to decide whether an analyte is scientifically necessary, to review bioanalytical method validation, or to review a single-analyte small-molecule programme.
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Quality Score: 84/100
Skill Content
Details
- Author
- malekokour
- Repository
- malekokour/clinpharm-pmx-skills
- Created
- 1 weeks ago
- Last Updated
- 6 days ago
- Language
- Python
- License
- MIT
Similar Skills
Semantically similar based on skill content — not just same category
review-bioanalytical-plan
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 plan requires a judgment it does not constrain. Use it for a draft plan, a calibration range check, or a reanalysis plan. Example: "Please a draft plan, a calibration range check." Do not use for the bioanalytical report and its validation results, for sampling times, for multi-analyte conjugate strategy, or to accept the method.
review-bioanalytical-report
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 this validation report against ICH M10" or "does the bioanalytical package support the concentrations behind these PK parameters". Do not use for verifying NCA derivations or parameter values, for reconciling a study report against its own sources, for re-validating or re-fitting the assay, or for any request to certify GLP or GCP compliance or to declare a method acceptable.
review-biomarker-target-engagement-strategy
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 target-engagement strategy; approve or submit related documents; select or adjust a dose; speak for the sponsor to an agency.