Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy

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, pra...

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Bibliographic Details
Published in:Annual review of pharmacology and toxicology 2021-01, Vol.61 (1), p.225-245
Main Authors: Darwich, Adam S, Polasek, Thomas M, Aronson, Jeffrey K, Ogungbenro, Kayode, Wright, Daniel F.B, Achour, Brahim, Reny, Jean-Luc, Daali, Youssef, Eiermann, Birgit, Cook, Jack, Lesko, Lawrence, McLachlan, Andrew J, Rostami-Hodjegan, Amin
Format: Article
Language:English
Subjects:
clinical decision support systems
electronic health records
individualized dosing
Medicin och hälsovetenskap
MIPD
model-informed precision dosing
pharmacokinetic pharmacodynamic modeling
systems pharmacology
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Summary: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.
ISSN:0362-1642
1545-4304
1545-4304
DOI:10.1146/annurev-pharmtox-033020-113257