Oral drug administration is the most convenient route of administration in the pediatric population. However, children are often not fasted when drugs are orally administered, hence potential food-drug interactions might occur. Most of these interactions are extrapolated from studies performed in human adults where a recommended high-fat, high-calorie meal is administered prior to drug dosing. As the recommended protocols are based on studies in support of adult drug development, these studies do not mimic the meal composition administered to the pediatric population, especially the very young ones, which renders food-drug interactions in this population understudied. Therefore, it was evaluated to what extent population pharmacokinetics could reliably extrapolate food effects from human adults and beagle dogs to mimic the real-life situation in the pediatric population. Eight human adults and six beagle dogs received ibuprofen under different dosing conditions (fasted, reference meal fed condition, infant formula fed condition). Population pharmacokinetic analysis was performed to derive the pharmacokinetic parameters to be scaled to pediatric ages. For both species, a one-compartment model best described the data, where in human adults a dual-input function to capture the double absorption peak significantly improved the model fit. Simulations for a virtual pediatric population demonstrated that the predictive ability of human adults and beagle dogs to inform absorption effects under different dosing conditions using population pharmacokinetic modeling appeared to be reasonable. However, to be able to fully validate the predictability of both species for ibuprofen, additional studies in the pediatric population are required to generate more informative data.
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