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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.", "summary_zh": "规划、执行并记录分析方法的验证、确认和转移，遵循ICH Q2(R2)和Q14、USP <1220>/<1225>/<1226>、ICH M10生物分析、CLSI EP或ISO/IEC 17025等管理框架。适用于HPLC、LC-MS/MS、GC、CE、ICP-MS、溶出度、qNMR、qPCR、NIR以及配体结合或细胞学检测，只要问题是方法是否适合其预期用途。触发词包括“方法验证”、“分析方法验证”、“AMV”、“验证方案”、“接受标准”、“线性”、“报告范围”、“准确度和精密度”、“重复性”、“中间精密度”、“回收率”、“LOD”、“LOQ”、“检测限”、“定量限”、“专属性”、“耐用性”、“方法转移”、“方法比较”、“Deming”、“Passing-Bablok”、“Bland-Altman”、“等效性检验”、“OOS调查”、“ICH Q2”、“Q2(R2)”、“Q14”、“USP 1225”、“ICH M10”、“生物分析中的已测样品再分析”、“ISR”、“CLSI EP”，以及任何要求证明检测有效性的请求。", "description_en": "This skill provides procedural guidance for planning, executing, and documenting analytical method validation, verification, and transfer. 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