Title

Pharmacokinetic studies in children: recommendations for practice and research.

Authors

Charlotte I S BarkerFollow
Joseph F Standing
Lauren E Kelly
Lauren Hanly Faught, Western University
Allison C Needham
Michael J Rieder, Western UniversityFollow
Saskia N de Wildt
Martin Offringa

Document Type

Article

Publication Date

7-1-2018

Journal

Archives of Disease in Childhood

Volume

103

Issue

7

First Page

695

Last Page

702

URL with Digital Object Identifier

10.1136/archdischild-2017-314506

Abstract

Optimising the dosing of medicines for neonates and children remains a challenge. The importance of pharmacokinetic (PK) and pharmacodynamic (PD) research is recognised both in medicines regulation and paediatric clinical pharmacology, yet there remain barriers to undertaking high-quality PK and PD studies. While these studies are essential in understanding the dose-concentration-effect relationship and should underpin dosing recommendations, this review examines how challenges affecting the design and conduct of paediatric pharmacological studies can be overcome using targeted pharmacometric strategies. Model-based approaches confer benefits at all stages of the drug life-cycle, from identifying the first dose to be used in children, to clinical trial design, and optimising the dosing regimens of older, off-patent medications. To benefit patients, strategies to ensure that new PK, PD and trial data are incorporated into evidence-based dosing recommendations are needed. This review summarises practical strategies to address current challenges, particularly the use of model-based (pharmacometric) approaches in study design and analysis. Recommendations for practice and directions for future paediatric pharmacological research are given, based on current literature and our joint international experience. Success of PK research in children requires a robust infrastructure, with sustainable funding mechanisms at its core, supported by political and regulatory initiatives, and international collaborations. There is a unique opportunity to advance paediatric medicines research at an unprecedented pace, bringing the age of evidence-based paediatric pharmacotherapy into sight.

Notes

Article available at Archives of Disease in Childhood

10.1136/archdischild-2017-314506

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 License.