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Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.

Germovsek, E; Barker, CIS; Sharland, M; Standing, JF (2019) Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance. Clin Pharmacokinet, 58 (1). pp. 39-52. ISSN 1179-1926 https://doi.org/10.1007/s40262-018-0659-0
SGUL Authors: Sharland, Michael Roy

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Abstract

Pharmacokinetic/pharmacodynamic (PKPD) modeling is important in the design and conduct of clinical pharmacology research in children. During drug development, PKPD modeling and simulation should underpin rational trial design and facilitate extrapolation to investigate efficacy and safety. The application of PKPD modeling to optimize dosing recommendations and therapeutic drug monitoring is also increasing, and PKPD model-based dose individualization will become a core feature of personalized medicine. Following extensive progress on pediatric PK modeling, a greater emphasis now needs to be placed on PD modeling to understand age-related changes in drug effects. This paper discusses the principles of PKPD modeling in the context of pediatric drug development, summarizing how important PK parameters, such as clearance (CL), are scaled with size and age, and highlights a standardized method for CL scaling in children. One standard scaling method would facilitate comparison of PK parameters across multiple studies, thus increasing the utility of existing PK models and facilitating optimal design of new studies.

Item Type: Article
Additional Information: © The Author(s) 2018 Open Access Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Correction available at: https://doi.org/10.1007/s40262-018-0723-9
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: Clin Pharmacokinet
ISSN: 1179-1926
Language: eng
Dates:
DateEvent
January 2019Published
19 April 2018Published Online
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
242146Seventh Framework Programmehttp://dx.doi.org/10.13039/501100004963
261060Seventh Framework Programmehttp://dx.doi.org/10.13039/501100004963
SP4650Action Medical Researchhttp://dx.doi.org/10.13039/501100000317
GN1834Action Medical Researchhttp://dx.doi.org/10.13039/501100000317
G1002305Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
M008665Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
ACF-2016-18-016National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
PubMed ID: 29675639
Go to PubMed abstract
URI: http://openaccess.sgul.ac.uk/id/eprint/109755
Publisher's version: https://doi.org/10.1007/s40262-018-0659-0

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