Physiologically Based Pharmacokinetics Modeling in the Neonatal Population-Current Advances, Challenges, and Opportunities

Physiologically based pharmacokinetic (PBPK) modeling is an approach to predicting drug pharmacokinetics, using knowledge of the human physiology involved and drug physiochemical properties. This approach is useful when predicting drug pharmacokinetics in under-studied populations, such as pediatrics. PBPK modeling is a particularly important tool for dose optimization for the neonatal population, given that clinical trials rarely include this patient population. However, important knowledge gaps exist for neonates, resulting in uncertainty with the model predictions. This review aims to outline the sources of variability that should be considered with developing a neonatal PBPK model, the data that are currently available for the neonatal ontogeny, and lastly to highlight the data gaps where further research would be needed.

Automated summary

Physiologically based pharmacokinetic (PBPK) modeling is a useful approach for predicting drug pharmacokinetics, especially in under-studied populations like pediatrics. However, there are important knowledge gaps for neonatal PBPK models, resulting in uncertainty in the predictions.