In February of 2024, the Product Quality Research Institute held a virtual workshop entitled “Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.” The workshop covered a range of topics related to pediatric formulation development and testing, including dissolution testing and applications to modeling drug absorption in developing pediatric patients. Workshop speakers reviewed the progress t...

Cytochrome P450 3A4 (CYP3A4) is a key target for time-dependent inhibition (TDI) assessment during drug development. However, translating in vitro TDI data to in vivo drug-drug interaction (DDI) risk remains challenging due to the acknowledged overestimation when incorporating in vitro kinetics in predictive models. We investigated different in vitro TDI assay conditions in human liver microsomes (HLM) and evaluated their impa...

The effect of food on pharmacokinetic properties of drugs is a commonly observed occurrence affecting about 40% of orally administered drugs. Within the pharmaceutical industry, significant resources are invested to predict and characterize a clinically relevant food effect. Here, the predictive performance of physiologically based pharmacokinetic (PBPK) food effect models was assessed via de novo mechanistic absorption models...