Application of a Pharmacokinetic Model to Inform the Optimal Dose for Individualized Drug Administration

Abstract Dose selection is critical in clinical settings and standard dosing protocols are not suitable for every patient, due to the significant degree of inter- and intra-individual variability of their pharmacokinetic response. Pharmacokinetic models can be used as clinical support tools to suggest individualized, optimal dosages according to each patient’s characteristics. We consider the case study of high-dose methotrexate administration for the application of a physiologically-based pharmacokinetic model, with the goal of obtaining model-informed dosages that we also compare with the standard dosing protocol. The results demonstrate the feasibility of this approach, the potential benefits of improved individualized dosages, and the importance of establishing rational and well-defined administration targets.