analytical-method-validation
Category: ideation-and-design · License: MIT · Version: 1.1 · Includes scripts
Tags: method validation, ICH Q2, bioanalysis, analytical chemistry, quality control
When to use it
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.Example requests
Ask your agent in plain language, for example:- “I have linearity data for my HPLC assay, r² is 0.999. Is that enough to say the calibration is linear?”
- “We’re moving our LC-MS/MS plasma PK assay from our lab to a CRO. I have run results in runs_batch3.csv with QC columns (level, nominal, measured) and I need to check whether batch 3 meets the guideline for a chromatographic assay, including the rule that each QC level has enough passing samples. Also, what’s the right way to check incurred sample reanalysis?”
- “Our QC lab is replacing an old HPLC method for an impurity with a faster UHPLC one. We ran 24 samples on both. A t-test gave p = 0.4 so my manager says they’re the same. I’d like to defend the switch to auditors. How should I do this properly?”
Install
/plugin marketplace add KalarisLabs/research-agent-skills and install the whole ideation-and-design category with /plugin install ideation-and-design@research-agent-skills.