review-adc-analyte-strategy

Solid

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 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.

Code & Development 6 stars 0 forks Updated 6 days ago MIT

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Skill Content

# ADC Analyte Strategy Review Check whether an antibody-drug conjugate's analyte set is defined consistently, measured where the programme's questions require it, and reported without internal contradiction across documents. Produce an analyte definition register, a question-to-analyte coverage matrix and a cross-analyte consistency table — for a qualified clinical pharmacologist to disposition. > **The recurring failure in ADC programmes is not a wrong number. It is the same > word meaning different things in different documents.** > > "Total antibody", "conjugated antibody", "ADC", "total payload", "free > payload" — these are defined per programme, and a protocol, a bioanalytical > plan and a CSR can each use one of them differently while every individual > document reads correctly. This skill compares the definitions. ## Why this is its own package The nearest neighbour is `review-csr-pk-consistency`, which compares one value against its source. This is a different shape: the risk is that **two documents agree numerically while disagreeing about what was measured**. Applying the six separability tests, four pass — distinct trigger (an ADC or multi-analyte question), distinct inputs (an analyte definition table and a bioanalytical plan), distinct neighbours (payload toxicology, DAR characterisation), distinct evolution (modality guidance moves independently). Merging requires all six to fail. ## Who this is for Clinical pharmacologists on ADC or multi-analyte progra...

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Author
malekokour
Repository
malekokour/clinpharm-pmx-skills
Created
1 weeks ago
Last Updated
6 days ago
Language
Python
License
MIT

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