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

Research output: Contribution to journalArticlepeer-review

  • External authors:
  • Adam Darwich
  • Thomas M Polasek
  • Jeffrey K. Aronson
  • Daniel F.B. Wright
  • Jean-Luc Reny
  • Youssef Daali
  • Birgit Eiermann
  • Jack Cook
  • Lawrence Lesko
  • Andrew J. McLachlan

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.

Bibliographical metadata

Original languageEnglish
JournalAnnual Review of Pharmacology and Toxicology
Volume61
Early online date9 Oct 2020
DOIs
Publication statusE-pub ahead of print - 9 Oct 2020