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Abstract
Interest in pediatric pharmacology has increased over the past two decades. With few exceptions, research efforts are currently, however, still limited to pharmacokinetic (PK) queries on single drugs in a limited number of subjects. It is now time to move forward and integrate and generalize the PK information that is currently available more efficiently across different drugs and different populations. Additionally, for pediatric patients to truly benefit from pharmacological research efforts, the knowledge that is obtained in these studies needs to be translated into dosing recommendations that are subsequently prospectively evaluated in adequately powered randomized clinical trials. Finally, as drug effects and safety are the result of both PK and pharmacodynamic (PD) processes and as developmental changes may occur in both processes, it is essential for PK studies to be followed-up by PD studies when dose-adjustments based on PKs alone have been proven insufficient. In this report, examples illustrating this approach are provided. As PD studies in children are generally more complicated to perform than PK studies, this is where a big challenge in pediatric pharmacological research still lies.
Declaration of interest
CAJ Knibbe received support from the Innovational Research Incentives Scheme (Vidi grant, July 2013) of the Dutch Organisation for Scientific Research (NWO). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.