analytical-method-validation

A guide to validating, verifying, and transferring analytical test methods such as HPLC, mass spectrometry, PCR, or cell-based assays. It uses the applicable laboratory or regulatory framework, including ICH, USP, CLSI, or ISO standards.

In plain words
What is it for?
Planning validation studies, checking compendial methods, moving a method to another laboratory or instrument, setting acceptance criteria, and documenting evidence for review or audits.
Why use it?
It helps prevent a test method from being judged against the wrong rules or against criteria chosen after seeing the results. It makes the intended use and acceptance requirements explicit before testing.

Skill for Claude CodeCodex

Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

agentmods
npx agentmods add skills/k-dense-ai/scientific-agent-skills/analytical-method-validation
Any agent
npx skills add K-Dense-AI/scientific-agent-skills --skill analytical-method-validation
Clone the repo
git clone --depth 1 https://github.com/K-Dense-AI/scientific-agent-skills

Made for: Claude Code, Codex.

Per session 281 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 4,118 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. Scan, not verified.
Origin original No closer match found in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5 $0.00281 $0.04118
Opus 5 $0.00140 $0.02059
Sonnet 5 $0.00056 $0.00824
Haiku 4.5 $0.00028 $0.00412

Measured yesterday against content hash 78e81a7713ef, method: parsed. Prices are Anthropic first-party input rates as of 2026-08-30, from the pricing page.

Security

Grade A, and why

analytical-method-validation scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured yesterday.

The scan reads SKILL.md. This mod also ships 8 executable files (scripts/_catalog.py, scripts/_common.py, scripts/check_accuracy_precision.py, …), listed below but not scanned — reading those needs a real analyzer, not pattern matching.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

skills/analytical-method-validation/SKILL.md · 300 lines

How it starts

The opening of the file, as written. The whole thing — 300 lines — stays where its author put it; the contents beside it link to each section on GitHub.

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 assays.

Scope

This skill plans studies, computes the statistics correctly, and structures the documentation. It does not decide that a procedure is validated, release a batch, accept or reject a run, close an investigation, or substitute for the analyst, the technical reviewer, the quality unit, or the regulator. Every script reports; none of them concludes.

ICH guidelines are published openly and licensed for reuse with acknowledgement, so their requirements are encoded directly in this skill. USP general chapters, CLSI EP documents, and ISO standards are copyrighted and paywalled. For those, this skill supplies the designation, scope, and where to obtain an authorised copy — never the text, never invented thresholds. Do not ask an agent to retrieve, transcribe, or reconstruct their content. If a number matters and it lives in a paywalled document, read it from the authorised copy.

Read the full file on GitHub · 300 lines

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. yesterday First seen · 300 lines · 281 tokens per session scan A 78e81a7713ef

Subscribe to this mod's changes

analytical-method-validation is a skill published in the GitHub repository K-Dense-AI/scientific-agent-skills (40,390 stars, last pushed yesterday), licensed MIT. It adds 281 tokens to every session and 4,118 once invoked, about $0.0014 per session on Opus 5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-08-30.

Related

Other skills, from other repositories

discovery-toolbox

A routed repertoire of 90 scientific thinking operators for biological research agents - visual reasoning, detectability and information budgets, search reframing, causal identification, competing explanations, observation and selection processes, pipeline artifact diagnosis, effort allocation, and confirmation…

dekan-aleksandr/biodiscovery-skills · 122 tokens

alphafold-pocket-evaluator

Parses AlphaFold2 PDB files, computes per-residue pLDDT confidence scores, and evaluates Solvent Accessible Surface Area (SASA) of active site pockets.

YuliaNuzhnenko/bioinformatics-agent-skills · 43 tokens

pydeseq2-bulk-rna

Automated negative binomial differential gene expression analysis, log2 fold-change calculation, p-value adjustment (FDR), and Volcano plot generation.

YuliaNuzhnenko/bioinformatics-agent-skills · 38 tokens

scanpy-sc-analyzer

Autonomous single-cell RNA-seq quality control filtering, Harmony batch-effect correction, Leiden clustering, UMAP visualization, and marker gene annotation.

YuliaNuzhnenko/bioinformatics-agent-skills · 34 tokens

card-amr-profiler

Scans bacterial genome assemblies against CARD (Comprehensive Antibiotic Resistance Database) and ResFinder to map drug-class resistance heatmaps.

YuliaNuzhnenko/bioinformatics-agent-skills · 32 tokens

diffdock-virtual-screener

Runs DiffDock generative diffusion models for blind protein-ligand docking against AlphaFold structures and ranks candidates by confidence scores.

YuliaNuzhnenko/bioinformatics-agent-skills · 33 tokens