analytical-method-validation

验证 分析方法 适配性

Plans, executes, and documents 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.

请帮我安装这个 Agent Skill：https://github.com/K-Dense-AI/scientific-agent-skills/tree/main/skills/analytical-method-validation

1. 先读取该目录下的 SKILL.md 和其他文件，检查是否有可疑内容（执行未知脚本、读取密钥、向外发送数据等），用中文告诉我它会做什么、需要哪些权限；
2. 等我确认后，再把整个目录安装到 ~/.claude/skills/analytical-method-validation/（如果你不是 Claude Code，安装到你自己约定的 skills 目录）；
3. 安装后告诉我怎么触发它。

git clone --depth 1 --filter=blob:none --sparse https://github.com/K-Dense-AI/scientific-agent-skills.git /tmp/analytical-method-validation-src
cd /tmp/analytical-method-validation-src && git sparse-checkout set "skills/analytical-method-validation"
mkdir -p ~/.claude/skills && cp -r "skills/analytical-method-validation" ~/.claude/skills/analytical-method-validation

Skill 可以让智能体执行脚本。安装第三方 Skill 前务必看一遍内容，详见「安全」一课。