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Pharmacokinetic studies in children: recommendations for practice and research.

Barker, CIS; Standing, JF; Kelly, LE; Hanly Faught, L; Needham, AC; Rieder, MJ; de Wildt, SN; Offringa, M (2018) Pharmacokinetic studies in children: recommendations for practice and research. Arch Dis Child, 103 (7). pp. 695-702. ISSN 1468-2044 https://doi.org/10.1136/archdischild-2017-314506
SGUL Authors: Barker, Charlotte Ida Sophia

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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.

Item Type: Article
Additional Information: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Keywords: dosing, neonatology, paediatrics, pharmacology, pharmacometrics, Pediatrics, 1103 Clinical Sciences, 1114 Paediatrics And Reproductive Medicine, 1117 Public Health And Health Services
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: Arch Dis Child
ISSN: 1468-2044
Language: eng
Dates:
DateEvent
July 2018Published
19 April 2018Published Online
14 March 2018Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
261060Seventh Framework Programmehttp://dx.doi.org/10.13039/501100004963
ACF-2016-18-016National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
G1002305Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
M008665Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
PubMed ID: 29674514
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/109851
Publisher's version: https://doi.org/10.1136/archdischild-2017-314506

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