State-of-the-Art Review on Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development

Clinical Pharmacokinetics
Venkata YellepeddiCatherine M T Sherwin

Abstract

Physiologically based pharmacokinetic modeling and simulation is an important tool for predicting the pharmacokinetics, pharmacodynamics, and safety of drugs in pediatrics. Physiologically based pharmacokinetic modeling is applied in pediatric drug development for first-time-in-pediatric dose selection, simulation-based trial design, correlation with target organ toxicities, risk assessment by investigating possible drug-drug interactions, real-time assessment of pharmacokinetic-safety relationships, and assessment of non-systemic biodistribution targets. This review summarizes the details of a physiologically based pharmacokinetic modeling approach in pediatric drug research, emphasizing reports on pediatric physiologically based pharmacokinetic models of individual drugs. We also compare and contrast the strategies employed by various researchers in pediatric physiologically based pharmacokinetic modeling and provide a comprehensive overview of physiologically based pharmacokinetic modeling strategies and approaches in pediatrics. We discuss the impact of physiologically based pharmacokinetic models on regulatory reviews and product labels in the field of pediatric pharmacotherapy. Additionally, we examine in detail the curre...Continue Reading

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Dec 18, 2018·Expert Opinion on Drug Metabolism & Toxicology·Anne SmitsKarel Allegaert
Dec 11, 2019·Pharmaceutics·Do Hee KimSeung Rim Hwang
Jan 12, 2020·Clinical Chemistry and Laboratory Medicine : CCLM·Camille RiffIsabelle Benz-de Bretagne
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Jun 30, 2021·Journal of Clinical Pharmacology·Alexander A Vinks, Jeffrey S Barrett
Jun 30, 2021·Journal of Clinical Pharmacology·Paul R V MalikBernd Meibohm

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