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Fundamentals of Pediatric Drug Dosing pp 109–125Cite as

Applications of Physiologically Based Pharmacokinetic (PBPK) Models for Pediatric Populations

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Abstract

Given the difficulties for conducting clinical studies in infants and children, pediatric pharmacometrics, which applies quantitative models to account maturation of biochemical and physiological aspects of development, to predict efficacy and the likelihood of adverse reactions, is being extensively applied during pediatric drug development. More specifically, pharmacokinetics, pharmacodynamics, and disease are evaluated in different subpopulations using different methodologies. Both the European Medicines Agency (EMA) and the FDA’s pharmacometrics initiative have influenced pediatric clinical design [41, 45]. Many pediatric pharmacometric examples are for drugs already on the market but used off-label in children to address the concerns on age-appropriate dose, efficacy, and safety in this special population.

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Authors and Affiliations

  1. Office of New Drug Products, Office of Product Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA

    Peng Duan PhD

  2. National Center for Toxicological Research, U.S. Food and Drug Administration, 3900 NCTR Rd, Jefferson, AR, 72079, USA

    Jeffrey W. Fisher PhD

  3. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA

    Jian Wang PhD

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  1. Clinical Pharmacology/Biopharmaceutics, Food & Drug Administration, Silver Spring, Maryland, USA

    Iftekhar Mahmood

  2. Clinical Pharmacology, Food & Drug Administration, Pediatric Group, Silver Spring, Maryland, USA

    Gilbert Burckart

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Duan, P., Fisher, J.W., Wang, J. (2016). Applications of Physiologically Based Pharmacokinetic (PBPK) Models for Pediatric Populations. In: Mahmood, I., Burckart, G. (eds) Fundamentals of Pediatric Drug Dosing. Adis, Cham. https://doi.org/10.1007/978-3-319-43754-5_8

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