analytical-method-validation
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", "repeatabi
npx skills add K-Dense-AI/scientific-agent-skills --skill analytical-method-validation --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# Analytical Method Validation ## When to use 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. ## The two rules **1. Establish which framework governs before designing anything.** The same assay validates differently under ICH Q2(R2), USP <1225>, ICH M10, CLSI EP, and ISO/IEC 17025. They differ in which characteristics are required, how the studies are laid out, and whether numeric acceptance criteria are supplied at all. Blending them produces a protocol that satisfies none of them. **2. State acceptance criteria before collecting data.** Criteria chosen after seeing results are not acceptance criteria, and deciding them post hoc is a standing audit finding. ICH Q2(R2) deliberately supplies almost no numeric criteria — they have to come from the specification, the analytical target profile (ICH Q14 section 3), or development data. ICH M10 is the exception: it supplies explicit numbers, and they differ between chromatographic assays and ligand binding
- 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
- 6. Bioanalytical runs under ICH M10
- 7. Transfer and method comparison
cd skills/analytical-method-validation/scripts python3 plan_validation.py --list-frameworks python3 plan_validation.py --framework ich-q2r2 --attribute assay --technique hplc --range-use assay python3 plan_validation.py --framework ich-q2r2 --attribute impurity --protocol > protocol.md python3 check_response.py -i calibration.csv --max-back-calc-error 2 python3 check_accuracy_precision.py -i ap.csv --accuracy-limit 2 --rsd-limit 1.0 --design-check assay python3 check_detection_limits.py --calibration lowcal.csv --blanks blanks.csv \ python3 check_bioanalytical_run.py --modality chromatographic --run run1.csv python3 check_bioanalytical_run.py --modality lba --isr isr.csv python3 check_bioanalytical_run.py --modality lba --criteria
What does the analytical-method-validation skill 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", "repeatabi
How do I install it?
Run `npx skills add K-Dense-AI/scientific-agent-skills --skill analytical-method-validation --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From K-Dense-AI/scientific-agent-skills, a repository with 32,619 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.