Understanding drug and drug formulation performance in relation to the prandial conditions is essential for ensuring the safety and efficacy of products to be administered to pediatric patients, especially newborns (birth – 27 days) and infants (28 days – 2 years) whose diet is specific (100% milk in newborns).
In recent years, there has been a growing interest in investigating whether food effect data collected in adults are useful for pediatric products as understanding the impact of prandial conditions on drug and drug product performance in pediatric patients is limited by ethical concerns and the subsequent difficulty to perform such studies. The recent guideline on how to conduct food effect studies for newly developed pediatric formulations issued by the FDA suggests that the food effect for pediatric formulations could be evaluated in adults using foods and quantities of food that are commonly consumed with drugs in pediatric populations with a subsequent extrapolation of the results to the pediatric population.
In the first part of the webinar, the focus will be on the design of food effects studies in adults for extrapolating oral drug absorption data to infants.
In the second part, extrapolation to infants based on adults’ data using in silico tools and, more specifically, PBPK modeling will be discussed.