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 KrekelsCatherijne A J Knibbe

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 regi...Continue Reading

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Sep 25, 2018·Journal of Clinical Pharmacology·John van den AnkerGregory L Kearns
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