Home » U.S. Bioanalytical Methods Guidance Defines Three Levels of Validation
U.S. Bioanalytical Methods Guidance Defines Three Levels of Validation
October 8, 2013
A U.S. Food and Drug Administration draft guidance on validating bioanalytical methods for evaluating drugs, their metabolites and biomarkers — techniques the agency calls “critical” for conducting successful clinical and nonclinical pharmacology studies — has been given a makeover 12 years after it was first issued.
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