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Perspectives on Model‐Informed Precision Dosing in the Digital Health Era: Challenges, Opportunities, and Recommendations
Author(s) -
Kluwe Franziska,
Michelet Robin,
MuellerSchoell Anna,
Maier Corinna,
KloppSchulze Lena,
Dyk Madelé,
Mikus Gerd,
Huisinga Wilhelm,
Kloft Charlotte
Publication year - 2021
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.2049
Subject(s) - dosing , precision medicine , medicine , computer science , data science , medical physics , management science , pharmacology , engineering , pathology
Drug approval is based on exposure, response, and variability of studied populations, typically excluding comorbidities/ medications and very ill patients, thus not representing realworld 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.