Physiologically based pharmacokinetic modeling is well established in the pharmaceutical industry and is accepted by regulatory agencies for the prediction of drug–drug interactions. However, physiologically based pharmacokinetic modeling is valuable to address a much wider range of pharmaceutical applications, and new regulatory impact is expected as its full power is leveraged. As one example, PBPK is already routinely used during drug discovery for in-vitro to in-vivo translation and pharmacokinetic modeling in preclinical species, and this leads to the application of verified models for first-in-human pharmacokinetic predictions.

This week’s available presentation is titled “Combining In-Vivo Animal Models with Physiologically Based Pharmacokinetics (PBPK) Modeling to Optimize Oral Formulation Dosage Forms” from Handan He / Tycho Haimbach at Novartis. This presentation overviews applications of PBPK absorption modeling tools. It also examines case examples of prediction on PPI effects, formulation dependent PBPK, food food effect predictions, comparison of IVIVC vs PBIVIVC and biorelevant permeability challenges, as well as overall recommendations.