Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development

Join Chief Scientist, Viera Lukacova, for a panel discussion during the PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations.

The purpose of this one-day workshop is to discuss the challenges, experiences, and advances related to the development of oral physiologically based pharmacokinetic (PBPK) absorption modeling to support the establishment of biopredictive in vitro testing (e.g., dissolution) and to address risks associated with the extrapolation of bioequivalence (BE) in various contexts, such as from a fasting to a fed state, from subjects with normal to elevated gastric pH, for a biopharmaceutics classification system (BCS)-based biowaiver, for assessing BE in pediatrics, and for other risk-based BE assessments for oral products.

Click here for more details and access to the full agenda.