Bioanalytics – Chemical
2019 PharmSci 360
Bioresearch Monitoring (BIMO) at the U.S. Food and Drug Administration (FDA) has a long tradition of ensuring the clinical and non-clinical research conducted in support of FDA regulated products supports the protection of study subjects, is compliant with FDA regulations and reliable to support regulatory decisions. My presentation will give an overview of how OSIS does surveillance inspections of firms that conduct pharmacokinetic, bioavailability/bioequivalence (BA/BE) studies to confirm that study data are reliable to support a regulatory decision. I will review some inspection findings from the analytical portions of bioavailability/bioequivalence studies and potential mitigation strategies based on scientific approaches.