Agent skill · research science · k-dense-ai
analytical-method-validation
Plan, 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.
Why this skill is useful
Adds domain-specific statistical methods and validation protocols for analytical procedures that the AI wouldn't reliably generate on its own.
What it needs
Requires python installed locally. About 10k tokens when loaded. Last updated 2026-08-03. 32,849 stars on the source repository.
What this skill does
Analytical Method Validation When to use Any time the question is whether an analytical procedure is fit for its intended purpose: designing a validation study, evaluating validation data, verifying a compendial procedure, transferring a procedure to another laboratory or instrument, or defending any of these in a report. The two rules 1. Establish which framework governs before designing anything. The same assay validates differently under ICH Q2(R2), USP <1225>, ICH M10, CLSI EP, and ISO/IEC 17025. They differ in which characteristics are required, how the studies are laid out, and whether numeric acceptance criteria are supplied at all. Blending them produces a protocol that satisfies none of them. 2. State acceptance criteria before collecting data. Criteria chosen after seeing results are not acceptance criteria, and deciding them post hoc is a standing audit finding. ICH Q2(R2) deliberately supplies almost no numeric criteria — they have to come from the specification, the analytical target profile (ICH Q14 section 3), or development data. ICH M10 is the exception: it supplies explicit numbers, and they differ between chromatographic assays and ligand binding assays. Scope This skill plans studies, computes the statistics correctly, and structures the documentation. It does not decide that a procedure is validated, release a batch, accept or reject a run, close an investigation, or substitute for the analyst, the technical reviewer, the quality unit, or the regulator. Every script reports; none of them concludes. Copyright boundary ICH guidelines are published openly and licensed for reuse with acknowledgement, so their requirements are encoded directly in this skill. USP general chapters, CLSI EP documents, and ISO standards are copyrighted and paywalled. For those, this skill supplies the designation, scope, and where to obtain an authorised copy — never the text, never invented thresholds. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills k-dense-ai/analytical-method-validation