Why has model-informed precision dosing not yet become common clinical reality? lessons from the past and a roadmap for the future.
Patient groups prone to polypharmacy and special subpopulations are susceptible to suboptimal treatment. Refined dosing in special populations is imperative to improve therapeutic response and/or lowering the risk of toxicity. Model-informed precision dosing (MIPD) may improve treatment outcomes by achieving the optimal dose for an individual patient. There is, however, relatively little published evidence of large-scale utility and impact of MIPD, where it is often implemented as local collaborative efforts between academia and healthcare. This article highlights some successful applications of bringing MIPD to clinical care and proposes strategies for wider integration in healthcare. Considerations are brought up herein that will need addressing to see MIPD become "widespread clinical practice," among those, wider interdisciplinary collaborations and the necessity for further evidence-based efficacy and cost-benefit analysis of MIPD in healthcare. The implications of MIPD on regulatory policies and pharmaceutical development are also discussed as part of the roadmap.
Centre for Applied Pharmacokinetic Research, Division of Pharmacy and Optometry, University of Manchester, Manchester, UK.
A S
AS
Darwich
Centre for Applied Pharmacokinetic Research, Division of Pharmacy and Optometry, University of Manchester, Manchester, UK.
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Ogungbenro
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.|Department of Pediatrics, University of Cincinnati School of medicine, Cincinnati, Ohio, USA.
A A
AA
Vinks
Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA.
J R
JR
Powell
Geneva Platelet Group, School of Medicine, University of Geneva, Geneva, Switzerland.|Department of Internal Medicine, Rehabilitation and Geriatrics, Geneva University Hospitals, Geneva, Switzerland.
J-L
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Reny
Clinical Pharmacology and Toxicology, Geneva University Hospitals, Geneva, Switzerland.
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Marsousi
Geneva Platelet Group, School of Medicine, University of Geneva, Geneva, Switzerland.|Clinical Pharmacology and Toxicology, Geneva University Hospitals, Geneva, Switzerland.
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Daali
Clinical Pharmacology Modeling and Simulation, GSK Stevenage, UK.
D
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Fairman
Clinical Pharmacology, Pfizer Inc, Groton, Connecticut, USA.
J
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Cook
Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida at Lake Nona (Orlando), Orlando, Florida, USA.
L J
LJ
Lesko
University of Washington Department of Pharmaceutics and Fred Hitchinson Cancer Research Center Clinical Research Division, Seattle, Washington, USA.
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JS
McCune
Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein, the Netherlands and Division of Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, the Netherlands.
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Knibbe
Department of Pharmacology and Toxicology, Radboud University, Nijmegen, the Netherlands.|Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands.
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de Wildt
Division of Pediatric Pharmacology and Medical Toxicology, Department of Pediatrics, Children's Mercy Hospitals and Clinics, Kansas City, Missouri, USA.|Department of Pharmacology, University of Missouri-Kansas City, Kansas City, Missouri, USA.
J S
JS
Leeder
University of Southern California and the Children's Hospital of Los Angeles, Los Angeles, California, USA.
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Neely
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
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Zuppa
Clinical Pharmacology, Pharmacometrics and DMPK, MedImmune, Cambridge, UK.
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Vicini
Centre for Applied Pharmacokinetic Research, Division of Pharmacy and Optometry, University of Manchester, Manchester, UK.
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Aarons
Certara, Blades Enterprise Centre, Sheffield, UK.
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Johnson
Epstein Becker & Green, Washington, DC, USA.
J
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Boiani
Centre for Applied Pharmacokinetic Research, Division of Pharmacy and Optometry, University of Manchester, Manchester, UK.|Epstein Becker & Green, Washington, DC, USA.
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Rostami-Hodjegan
D003362:Cost-Benefit Analysis; D019033:Delivery of Health Care, Integrated; D005544:Forecasting; D006801:Humans; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D057285:Precision Medicine / Q000639:trends*
D004364:Pharmaceutical Preparations