A Mechanistic Physiologically-Based Biopharmaceutics Modeling Approach to Assess the in vivo Performance of an Orally Administered Drug Product: From IVIVC to IVIVP

The application of in silico modeling to predict the in vivo outcome of an oral drug product is gaining a lot of interest. Fully relying on these models as a surrogate tool requires continuous optimization and validation. Establishing the link between biopredictive in vitro dissolution testing and mechanistic oral absorption modeling (i.e., physiologically-based biopharmaceutics modeling (PBBM)) creates an opportunity to potentially request biowaivers in the near future for orally administered drug products, regardless of its classification according to the Biopharmaceutics Classification System (BCS). To learn more, please view our publication.