Overview
analytical-method-validation is an open-source data skill for Claude Code and compatible agents, published by K-Dense-AI. Its author describes it as: “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 1702…”. The project has 46k stars on GitHub and is available under the MIT license. Add it to your setup with `git clone https://github.com/K-Dense-AI/scientific-agent-skills ~/.claude/skills/analytical-method-validation`.
What analytical-method-validation does
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.
What’s inside
The SKILL.md for analytical-method-validation is organised into these sections:
- When to use
- The two rules
- Scope
- Copyright boundary
- Frameworks
- Scripts
- Workflow
- 1. Fix the framework and the required characteristics
- 2. Generate the protocol and fill in the criteria
- 3. Evaluate the response
- 4. Evaluate accuracy and precision
- 5. Establish DL and QL, and confirm them
Installation
Add analytical-method-validation to your agent with:
git clone https://github.com/K-Dense-AI/scientific-agent-skills ~/.claude/skills/analytical-method-validationReview a skill’s source before installing it — skills can instruct your agent to run commands. This command comes from the skill’s public repository, which is the source of truth for setup steps. New to skills? Read how to install Claude Code skills.
Supported agents
Neither the skill nor its repository names a specific agent. It uses the SKILL.md format, which several agents can load — check the repository for any agent-specific requirements.
License
analytical-method-validation is published under the MIT license.
Strengths
- Clear MIT license — safe to read and adapt within its terms
- Ships in K-Dense-AI/scientific-agent-skills, an established project with 45,887 GitHub stars
- Actively maintained — repository updated in the last 30 days
- Its repository gained 12,066 GitHub stars over the last 34 days
Author
Topics
Frequently asked questions
- What does analytical-method-validation do?
- 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.
- How do I install analytical-method-validation?
- Run git clone https://github.com/K-Dense-AI/scientific-agent-skills ~/.claude/skills/analytical-method-validation in your agent, then reload your skills. Review the source at https://github.com/K-Dense-AI/scientific-agent-skills before installing.
- Is analytical-method-validation free to use?
- Yes. analytical-method-validation is free and open source under the MIT license, so you can read, run, and adapt it within that license's terms.
- Where does analytical-method-validation come from?
- analytical-method-validation ships inside K-Dense-AI/scientific-agent-skills, a repository that contains 42 catalogued skills in total. The repository's 45,887 GitHub stars apply to that whole collection, not to this skill on its own.