Use of Modeling and Simulation in the Design and Conduct of Pediatric Clinical Trials and the Optimization of Individualized Dosing Regimens

CPT: Pharmacometrics & Systems Pharmacology
Chris StockmannCmt Sherwin

Abstract

Mathematical models of drug action and disease progression can inform pediatric pharmacotherapy. In this tutorial, we explore the key issues that differentiate pediatric from adult pharmacokinetic (PK) / pharmacodynamic (PD) studies, describe methods to calculate the number of participants to be enrolled and the optimal times at which blood samples should be collected, and therapeutic drug monitoring methods for individualizing pharmacotherapy. The development of pediatric-specific drug dosing dashboards is also highlighted, with an emphasis on clinical-relevance and ease of use.

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Citations

Apr 16, 2016·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Nitin MehrotraVikram Sinha
Jun 30, 2016·British Journal of Clinical Pharmacology·Michael Rieder, Daniel Hawcutt
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Apr 16, 2021·The Journal of Antimicrobial Chemotherapy·Zoe KaneJoseph F Standing
Mar 3, 2021·Clinical and Translational Science·Fei TangMarkos Leggas
Aug 2, 2021·European Journal of Drug Metabolism and Pharmacokinetics·Yang ChenChuanpu Hu
Aug 6, 2017·Pediatrics·Delesha CarpenterBenjamin Wilfond

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Methods Mentioned

BETA
PMA
pharmacotherapy

Software Mentioned

NONMEM
PFIM
WinPOPT
PopDes
ADAPT
PopED
R
Tableau
Cognos
POPT

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