analytical-method-validation

by K-Dense-AI 34k MIT Updated Aug 17, 2026
analytical-method-validation skill by K-Dense-AI
analytical-method-validation — Data skill by K-Dense-AI

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 34k 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.

Installation

Add analytical-method-validation to your agent with:

git clone https://github.com/K-Dense-AI/scientific-agent-skills ~/.claude/skills/analytical-method-validation

Always review a skill's source before installing it. This command comes from the skill's public repository; the linked repo is the source of truth for exact setup steps.

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

When to use it

Reach for analytical-method-validation when you want data help from your agent without writing the same instructions every session. Load the skill and the agent picks it up automatically for relevant tasks.

Strengths

  • Clear MIT license — safe to read and adapt
  • Ships in K-Dense-AI/scientific-agent-skills, an established project with 33,821 GitHub stars
  • Actively maintained (recent commits)

Topics

agent-skillsai-scientistbioinformaticschemoinformaticsclaudeclaude-skillsclaudecodeclinical-researchcomputational-biologydata-analysisdrug-discoverygenomicsmaterials-sciencemetabolomicsproteomicsscientific-computingscientific-visualization

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 41 catalogued skills in total. The repository's 33,821 GitHub stars apply to that whole collection, not to this skill on its own.

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