Presentation Description: Simple mistakes in drug development can compromise study data reliability. Examples of such mistakes are; drug packager mislabeling drug bottles for a blinded pivotal bioequivalence study, a clinical site retaining reserves from only one drug shipment, although it received multiple shipments, and a laboratory conducting stability experiments without comparator samples made from fresh stock solutions. Bioresearch Monitoring (BIMO) at the U.S. Food and Drug Administration (FDA) is tasked with the responsibility of ensuring that clinical and non-clinical study data conducted in support of FDA regulated products support human subject protection, are compliant with FDA regulations, and reliable to support regulatory decisions. In this presentation, I will give some FDA and office updates and I will present findings from recent inspections involving clinical and analytical portions of bioavailability/bioequivalence studies. I will also discuss implication of the findings on the studies by utilizing scientific approaches.
Upon completion, participant will learn how FDA conducts comprehensive study-directed and surveillance inspections of firms
Upon completion, participant will learn about recent inspectional findings involving clinical and analytical portions of bioavailability/bioequivalence studies and gain a better overall understanding of FDA’s requirements and processes
'Upon completion, participant will be able to evaluate data integrity/reliability using case examples