TY - JOUR
T1 - Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy
AU - Darwich, Adam
AU - Polasek, Thomas M
AU - Aronson, Jeffrey K.
AU - Ogungbenro, Kayode
AU - Wright, Daniel F.B.
AU - Achour, Brahim
AU - Reny, Jean-Luc
AU - Daali, Youssef
AU - Eiermann, Birgit
AU - Cook, Jack
AU - Lesko, Lawrence
AU - McLachlan, Andrew J.
AU - Rostami-Hodjegan, Amin
N1 - Funding Information:
T.M.P. and A.R.-H. are employed part-time by Certara, a company that develops and supplies modeling and simulation software and services to the pharmaceutical industry. A.R.-H. is the director of the Centre for Applied Pharmacokinetic Research (University of Manchester), whose research is funded by a consortium of pharmaceutical companies. J.C. is employed and compensated by Pfizer Inc.
Publisher Copyright:
Copyright © 2021 by Annual Reviews. All rights reserved.
PY - 2020/10/9
Y1 - 2020/10/9
N2 - 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-care economics, and drug regulations.
AB - 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-care economics, and drug regulations.
KW - Clinical decision support systems
KW - Electronic health records
KW - Individualized dosing
KW - MIPD
KW - Model-informed precision dosing
KW - Pharmacokinetic/ pharmacodynamic modeling
KW - Systems pharmacology
U2 - 10.1146/annurev-pharmtox-033020-113257
DO - 10.1146/annurev-pharmtox-033020-113257
M3 - Review article
SN - 0362-1642
VL - 61
JO - Annual Review of Pharmacology and Toxicology
JF - Annual Review of Pharmacology and Toxicology
ER -