Demonstrating Virtual Bioequivalence (VBE) using the Simcyp Simulator™

Demonstrating Virtual Bioequivalence (VBE) using the Simcyp Simulator™

Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval. As a result, some branded drugs remain on the market well past the originator’s patent expiration, without cost-effective generic alternatives that could benefit patients. Model-informed drug development (MIDD), specifically physiologically-based pharmacokinetics (PBPK) leveraging in vitro data, is a proven, cost-effective option to consider in lieu of running an in vivo comparative clinical BE endpoint study

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