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Krekels EHJ, van Hasselt JGC, van den Anker JN, et al. Evidence-based drug treatment for special patient populations through model-based approaches. Eur J Pharm Sci. 2017;109:S22-S26doi: 10.1016/j.ejps.2017.05.022.
Krekels, E. H. J., van Hasselt, J. G. C., van den Anker, J. N., Allegaert, K., Tibboel, D., & Knibbe, C. A. J. (2017). Evidence-based drug treatment for special patient populations through model-based approaches. European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 109S22-S26. https://doi.org/10.1016/j.ejps.2017.05.022
Krekels, Elke H J, et al. "Evidence-based drug treatment for special patient populations through model-based approaches." European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences vol. 109 (2017): S22-S26. doi: https://doi.org/10.1016/j.ejps.2017.05.022
Krekels EHJ, van Hasselt JGC, van den Anker JN, Allegaert K, Tibboel D, Knibbe CAJ. Evidence-based drug treatment for special patient populations through model-based approaches. Eur J Pharm Sci. 2017 Nov 15;109:S22-S26. doi: 10.1016/j.ejps.2017.05.022. Epub 2017 May 11. PMID: 28502674.
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Eur J Pharm Sci. 2017 Nov 15;109:S22-S26. doi: 10.1016/j.ejps.2017.05.022. Epub 2017 May 11.

Evidence-based drug treatment for special patient populations through model-based approaches.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

Elke H J Krekels, J G Coen van Hasselt, John N van den Anker, Karel Allegaert, Dick Tibboel, Catherijne A J Knibbe

Affiliations

  1. Leiden Academic Center for Drug Research, Systems Pharmacology Cluster, Division of Pharmacology, Leiden University, Leiden, The Netherlands. Electronic address: [email protected].
  2. Leiden Academic Center for Drug Research, Systems Pharmacology Cluster, Division of Pharmacology, Leiden University, Leiden, The Netherlands; Department of Pharmacological Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  3. Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands; Division of Clinical Pharmacology, Children's National Health System, Washington, DC, USA; Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel, Switzerland.
  4. Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands; Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
  5. Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.
  6. Leiden Academic Center for Drug Research, Systems Pharmacology Cluster, Division of Pharmacology, Leiden University, Leiden, The Netherlands; Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein, The Netherlands.

PMID: 28502674 DOI: 10.1016/j.ejps.2017.05.022

Abstract

The majority of marketed drugs remain understudied in some patient populations such as pregnant women, paediatrics, the obese, the critically-ill, and the elderly. As a consequence, currently used dosing regimens may not assure optimal efficacy or minimal toxicity in these patients. Given the vulnerability of some subpopulations and the challenges and costs of performing clinical studies in these populations, cutting-edge approaches are needed to effectively develop evidence-based and individualized drug dosing regimens. Five key issues are presented that are essential to support and expedite the development of drug dosing regimens in these populations using model-based approaches: 1) model development combined with proper validation procedures to extract as much valid information from available study data as possible, with limited burden to patients and costs; 2) integration of existing data and the use of prior pharmacological and physiological knowledge in study design and data analysis, to further develop knowledge and avoid unnecessary or unrealistic (large) studies in vulnerable populations; 3) clinical proof-of-principle in a prospective evaluation of a developed drug dosing regimen, to confirm that a newly proposed regimen indeed results in the desired outcomes in terms of drug concentrations, efficacy, and/or safety; 4) pharmacodynamics studies in addition to pharmacokinetics studies for drugs for which a difference in disease progression and/or in exposure-response relation is anticipated compared to the reference population; 5) additional efforts to implement developed dosing regimens in clinical practice once drug pharmacokinetics and pharmacodynamics have been characterized in special patient populations. The latter remains an important bottleneck, but this is essential to truly realize evidence-based and individualized drug dosing for special patient populations. As all tools required for this purpose are available, we have the moral and societal obligation to make safe and effective pharmacotherapy available for these patients too.

Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Keywords: Children; Clinical pharmacology; Critically-ill; Evidence-based dosing; Obese; Special patient populations

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