> ## Documentation Index
> Fetch the complete documentation index at: https://docs.kalarislabs.com/llms.txt
> Use this file to discover all available pages before exploring further.

# analytical-method-validation — AI agent skill for ideation and design

> Plans and evaluates analytical method validation, verification, and transfer using Python scripts (plan_validation, check_response, check_accuracy_precisi…

# `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.

**Category:** [ideation-and-design](/research-agent-skills/skills#ideation-and-design) · **License:** MIT · **Version:** 1.1

## Install

```bash theme={null}
npx research-agent-skills install analytical-method-validation
npx skills add KalarisLabs/research-agent-skills --skill analytical-method-validation
```

## 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.

## Full playbook

Read [SKILL.md](https://github.com/KalarisLabs/research-agent-skills/blob/main/skills/analytical-method-validation/SKILL.md) for the complete workflow, references and any scripts. The agent installer copies the full skill folder.


This documentation is built and hosted on [Mintlify](https://mintlify.com), a developer documentation platform.