A UL course
FDA inspects the facilities of the sponsors or their contractors who conduct bioequivalence studies, under the In Vivo Bioequivalence Compliance Program. It is one of the seven compliance programs of the Bioresearch Monitoring (BIMO) Program. Included in the FDA inspections are the clinical facilities where bioequivalence studies are conducted (i.e., subjects are enrolled, dosed, and biological samples are collected) and analytical facilities where biological samples are analyzed to determine the concentrations of the drug. This course will introduce you to some brand name and generic drugs, explain the importance of bioavailability, and describe the underlying concept of bioequivalence for comparison of drug performance. This course will also discuss the implementation of the in vivo bioequivalence compliance program.
- Identify steps to prepare for an inspection
- Electronic signatures
- System documentation
- Audit trails