Toward Dynamic Prescribing Information: Codevelopment of Companion Model-Informed Precision Dosing Tools in Drug Development

Thomas M. Polasek, Craig R. Rayner, Richard W. Peck, Andrew Rowland, Holly Kimko, Amin Rostami-Hodjegan

Research output: Contribution to journalComment/debate

9 Citations (Scopus)

Abstract

Model-informed precision dosing (MIPD) is biosimulation in healthcare to predict the drug dose for a given patient based on their individual characteristics that is most likely to improve efficacy and/or lower toxicity compared with traditional dosing. Despite widespread use of biosimulation in drug development, MIPD has not been adopted beyond academic-hospital centers. A reason for this is that MIPD requires more supporting evidence in the language that everyday doctors understand—evidence-based medicine. In this commentary, codevelopment of companion MIPD tools during drug development is advocated as a way to accelerate the generation of the evidence required for broader clinical implementation of MIPD. Such tools have the potential to evolve into “dynamic” prescribing information that could guide dose selection for complex patients.

Original languageEnglish
Pages (from-to)418-425
Number of pages8
JournalClinical Pharmacology in Drug Development
Volume8
Issue number4
DOIs
Publication statusPublished - May 2019

Keywords

  • drug development
  • model-informed precision dosing
  • physiologically based pharmacokinetics
  • precision dosing
  • precision medicine

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