Perspectives on Model-Informed Precision Dosing in the Digital Health Era: Challenges, Opportunities, and Recommendations

Abstract

Drug approval is based on exposure, response, and variability of studied populations, typically excluding comorbidities/medications and very ill patients, thus not representing real‐world populations. This results in wide variability in therapeutic outcome for individual patients. Model‐informed precision dosing (MIPD) can characterize/quantify this variability, support optimal dose selection, and enable individualized therapy. The aim of this perspective is to raise awareness for MIPD, identify challenges hindering its implementation in clinical practice, provide recommendations, and highlight opportunities.