The Complete Guidance To Bioanalytical Method Validation For 2020

Bioanalytical method validation remains the cornerstone of success for any non-clinical and clinical drug development program. This provides quantitation of various factors that affect drug efficacy and safety. These include drug metabolites, analytes, and where applicable, biomarkers. It remains a regulatory requirement and there are relevant FDA bioanalytical method validation guidelines available. Similar guidelines are […]

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