analytical-method-validation
FeaturedPlan, execute, and document validation, verification, and transfer of analytical procedures under the governing framework - ICH Q2(R2) and Q14, USP <1220>/<1225>/<1226>, ICH M10 bioanalytical, CLSI EP, or ISO/IEC 17025. Use for HPLC, LC-MS/MS, GC, CE, ICP-MS, dissolution, qNMR, qPCR, NIR, and ligand binding or cell-based assays whenever the question is whether a procedure is fit for its intended purpose. Triggers include "method validation", "analytical method validation", "AMV", "validation protocol", "acceptance criteria", "linearity", "reportable range", "accuracy and precision", "repeatability", "intermediate precision", "recovery", "LOD", "LOQ", "detection limit", "quantitation limit", "specificity", "robustness", "method transfer", "method comparison", "Deming", "Passing-Bablok", "Bland-Altman", "equivalence testing", "OOS investigation", "ICH Q2", "Q2(R2)", "Q14", "USP 1225", "ICH M10", "incurred sample reanalysis", "ISR", "CLSI EP", and any request to show that an assay works.
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Quality Score: 99/100
Skill Content
Details
- Author
- K-Dense-AI
- Repository
- K-Dense-AI/scientific-agent-skills
- Created
- 10 months ago
- Last Updated
- today
- Language
- Python
- License
- MIT
Similar Skills
Semantically similar based on skill content — not just same category
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-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-blq-and-time-deviation-rules
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 reconciles collected minus excluded against analysed. Use it for an analysis plan before derivation, or afterwards to establish what was actually applied. Example: "Please an analysis plan before derivation." Do not use for NCA parameter verification, for NCA dual-control oversight, for the modelling plan as a whole, for assay validation, or to decide which handling method is correct.