In this presentation, we will discuss some problem areas in predicting oral drug absorption using case studies, including understanding and predicting food, PPI and formulation effects on oral drug absorption. Applying an in vitro-in silico (PBBM) approach, data for the solubility of the drug , in vitro dissolution profiles of the drug product and drug permeability will be combined with PBPK models to generate simulations of the clinical study plasma profiles. Once the PBBM model has been verified, this approach has the advantage of enabling simulation of a host of potential scenarios, including an examination of the interplay among drug characteristics, the formulation and the GI physiology. Thus, root causes of variability in PK, food effects, absorption related DDIs and differences between formulations can be determined.
Upon completion, participant will be able to understand how physiology can influence the release of an API from the dosage form
Upon completion, participant will be able to select appropriate dissolution tests designs to predict food effects
Upon completion, participant will be able to select appropriate dissolution tests designs to predict supersaturation / precipitation in the GI tract