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Medical Devices, Pharmaceuticals

BIMO In Vitro Bioequivalence Program Part I

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.