Bioanalytical Method Validation and Study Sample Analysis M10 by ICH
= Bioanalytical Method Validation and Study Sample Analysis M10 by ICH
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https://database.ich.org/sites/default/files/M10_Guideline_Step4_2022_0524.pdf
ICH harmonised guideline, final version adopted24May2022. Sections7.1.1–7.1.3 distinguish surrogate matrices and surrogate analytes and discuss response comparability, matrix effects and recovery. Glossary, Surrogate Matrix, gives the alternative-matrix definition.