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.

Version: 1.1
License: MIT
Compatibility: Requires Python 3.11+. Scripts use only the standard library - no numpy, scipy, or network access. Statistical distributions are computed from first principles so results are reproducible in any conforming interpreter.

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