Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy
Adam S. Darwich, Thomas M. Polasek, Jeffrey K Aronson, Kayode Ogungbenro, Daniel F. B. Wright, Brahim Achour, Jean‐Luc Reny, Youssef Daali, Birgit Eiermann, Jack Cook, Lawrence J. Lesko, Andrew J. McLachlan, Amin Rostami‐Hodjegan
Abstract
Model-informed precision dosing (MIPD) has become synonymous with modern approaches for individualizing drug therapy, in which the characteristics of each patient are considered as opposed to applying a one-size-fits-all alternative. This review provides a brief account of the current knowledge, practices, and opinions on MIPD while defining an achievable vision for MIPD in clinical care based on available evidence. We begin with a historical perspective on variability in dose requirements and then discuss technical aspects of MIPD, including the need for clinical decision support tools, practical validation, and implementation of MIPD in health care. We also discuss novel ways to characterize patient variability beyond the common perceptions of genetic control. Finally, we address current debates on MIPD from the perspectives of the new drug development, health economics, and drug regulations.