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Pediatric pharmacokinetics and dose predictions: a report of a satellite meeting to the 10th Juvenile Toxicity Symposium

van Groen, Bianca D. and Pilla Reddy, Venkatesh and Badee, Justine Marine and Olivares-Morales, Andrés and Johnson, Trevor N. and Nicolaï, Johan and Annaert, Pieter and Smith, Anna and de Wildt, Saskia N. and Knibbe, Catherijne A. J. and de Zwart, Loeckie (2020) Pediatric pharmacokinetics and dose predictions: a report of a satellite meeting to the 10th Juvenile Toxicity Symposium. Clinical and translational science. ISSN 1752-8062

Abstract

On the 24th of April 2019 a symposium on Pediatric pharmacokinetics and dose predictions was held as a satellite meeting to the 10th Juvenile Toxicity Symposium. The aim of this meeting was to bring together scientists from academia, industry and clinical research organizations to update each other on the current knowledge on pediatric drug development. The increased knowledge on specific ontogeny profiles of drug metabolism and transporter proteins, integrated into physiologically based pharmacokinetic (PBPK) models has allowed a more integrated understanding of age-related differences in PK, for which examples were given during the meeting. PBPK may be considered the gold-standard for pediatric PK prediction, but still it is important to know that simpler methods like allometry, allometry combined with maturation function, functions based on the elimination pathway or linear models also perform well depending on the age range or the mechanisms involved. It is important to combine knowledge from different methods and information sources; e.g. techniques like microdosing can gain early read-out of age-related differences in exposure and in addition such results can be value to verify models. To further establish best practices for dose setting in pediatrics more in vitro and in vivo research is needed on such aspects as age related changes in the exposure response relationship and also the impact of disease on PK. New information coupled with the refining of model based drug development approaches will allow faster targeting of intended age groups and allow more efficient design of pediatric clinical trials.

Item Type: Article
Date Deposited: 11 Aug 2020 00:45
Last Modified: 11 Aug 2020 00:45
URI: https://oak.novartis.com/id/eprint/42511

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