Individual skill
analytical-method-validation
Plans and evaluates analytical method validation, verification, and transfer using Python scripts (plan_validation, check_response, check_accuracy_precision, check_detection_limits, check_bioanalytical_run, compare_methods) under ICH Q2(R2)/Q14, ICH M10, USP 1220/1225/1226, CLSI EP, or ISO/IEC 17025. Covers protocols, linearity, accuracy and precision, DL/QL, M10 run checks, TOST equivalence, Deming and Passing-Bablok. Use when designing a validation protocol with pre-stated acceptance criteria. Use when evaluating linearity, precision, or detection limit data. Use when checking an ICH M10 bioanalytical run or ISR. Use when comparing or transferring a method between labs. Does not decide a method is validated; USP, CLSI, ISO text is not supplied.
plugins/KalarisLabs/research-agent-skills/skills/analytical-method-validation/SKILL.md
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# 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