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How to optimise drug study design: pharmacokinetics and pharmacodynamics studies introduced to paediatricians

Vermeulen, E; van den Anker, JN; Della Pasqua, O; Hoppu, K; van der Lee, JH; Global Research in Paediatrics (GRiP), .; (2017) How to optimise drug study design: pharmacokinetics and pharmacodynamics studies introduced to paediatricians. Journal of Pharmacy and Pharmacology , 69 (4) pp. 439-447. 10.1111/jphp.12637. Green open access

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Abstract

OBJECTIVES: In children, there is often lack of sufficient information concerning the pharmacokinetics (PK) and pharmacodynamics (PD) of a study drug to support dose selection and effective evaluation of efficacy in a randomised clinical trial (RCT). Therefore, one should consider the relevance of relatively small PKPD studies, which can provide the appropriate data to optimise the design of an RCT. METHODS: Based on the experience of experts collaborating in the EU-funded Global Research in Paediatrics consortium, we aimed to inform clinician-scientists working with children on the design of investigator-initiated PKPD studies. KEY FINDINGS: The importance of the identification of an optimal dose for the paediatric population is explained, followed by the differences and similarities of dose-ranging and efficacy studies. The input of clinical pharmacologists with modelling expertise is essential for an efficient dose-finding study. CONCLUSIONS: The emergence of new laboratory techniques and statistical tools allows for the collection and analysis of sparse and unbalanced data, enabling the implementation of (observational) PKPD studies in the paediatric clinic. Understanding of the principles and methods discussed in this study is essential to improve the quality of paediatric PKPD investigations, and to prevent the conduct of paediatric RCTs that fail because of inadequate dosing.

Type: Article
Title: How to optimise drug study design: pharmacokinetics and pharmacodynamics studies introduced to paediatricians
Open access status: An open access version is available from UCL Discovery
DOI: 10.1111/jphp.12637
Publisher version: http://dx.doi.org/10.1111/jphp.12637
Language: English
Additional information: This is the peer reviewed version of the following article: Vermeulen, E., van den Anker, J. N., Della Pasqua, O., Hoppu, K., van der Lee, J. H. and Global Research in Paediatrics (GRiP) (2016), How to optimise drug study design: pharmacokinetics and pharmacodynamics studies introduced to paediatricians. J Pharm Pharmacol., which has been published in final form at http://dx.doi.org/10.1111/jphp.12637. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
Keywords: paediatrics, pharmacodynamics, pharmacokinetics
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmacology
URI: https://discovery.ucl.ac.uk/id/eprint/1519986
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