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Peer-Reviewed Publication
J Pharmacokinet Pharmacodyn2026;53(5)July 29, 2026Journal Article

Strategies for pediatric dose derivation from population pharmacokinetic models.

Andreas Krause1,2, Géraldine Cellière3
1Clinical Pharmacology and Pharmacometrics, Simulations Plus, Inc, PO Box 12317, Research Triangle Park, NC, 27709, USA.
2Pharmacometrics.Swiss GmbH, Basel, Switzerland.
3Clinical Pharmacology and Pharmacometrics, Simulations Plus, Inc, PO Box 12317, Research Triangle Park, NC, 27709, USA. geraldine.celliere@simulations-plus.com.

Abstract

Health authorities worldwide require clinical studies in children to ensure scientifically rigorous and consistent dosing. Before pediatric data are available, model-based methods provide a scientific and reproducible way to determine doses for pediatric studies. A general introduction to pediatric scaling is provided, followed by a focus on population pharmacokinetic methods to scale from adults…

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