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Literature

Guidelines

ICH M10 on bioanalytical method validation – Scientific guideline, EMA, July 2022
Document available at: https://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation-scientific-guideline

M10 Bioanalytical Method Validation and Study Sample Analysis, FDA, November 2022.
Document available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m10-bioanalytical-method-validation-and-study-sample-analysis

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