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Medical Devices, Pharmaceuticals

BIMO In Vivo Bioequivalence Program Part II

About the 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 eLearning course will introduce you to the challenges of inspecting clinical and analytical facilities and the various technical terms commonly used in bioavailability and bioequivalence studies.