Application of pharmacokinetic-pharmacodynamic modeling and simulation for erythropoietic stimulating agents

Abstract

Rigorous management of the knowledge generated with the modeling techniques requires the exploration of different scenarios of interest via simulations, which can be used to inform many key decisions during drug development. This process, termed model-based drug development, is illustrated in three examples at different stages of drug development of erythropoiesis stimulating agents (ESA). Each of these examples reflects an actual situation with key decisions made based on the knowledge obtained from these models. One of the beneficial outcomes of the modeling and simulation approach is to elicit discussion in the development team on the unverifiable assumptions at each stage and to guide risk calculations in decision making. This approach can facilitate the development of better dosing regimens of new medicines, which may lead to enhanced benefit of the drug therapy and improvements in the quality of life of the patients. © American Association of Pharmaceutical Scientists 2011.