VICH GL1 Validation of analytical procedures: definition and terminology - Scientific guideline
VeterinaryScientific guidelines
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This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as a part of registration applications submitted within the European Union, Japan and USA.
Keywords: Validation, analytical procedures, accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, VICH, veterinary medicinal product (VMP)