Know The Basics: 5 Crucial Approaches Of Bioanalytical Assay Development and Validation
Sponsors regularly apply for IND, ANDA, and NDA submissions to the FDA. For successful drug applications, sponsors must conduct clinical pharmacology, bioavailability, bioequivalence, and pharmacokinetic assessments and demonstrate the safety and efficacy of a drug product. Hence, sponsors must develop and validate bioanalytical assays to …