Demonstrating Virtual Bioequivalence (VBE) using the Simcyp SimulatorTM Dr. Sebastian Polak, Senior Scientific Advisor and Head of Mechanistic Dermal Modelling of Certara’s Simcyp division2 What is Bioequivalence (BE)? The US FDA has defined BE as, “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study”. In clinical BE studies, an applicant compares the systemic exposure profile of a test drug product to that of a reference drug product. As clinical BE studies can be costly and time-consuming, there i

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