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Modeling and Simulation in Pediatric Research and Development

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Clinical Trial Simulations

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 1))

Abstract

Pediatric research and development is typically poorly funded in both academic and industrial settings creating greater incentive for optimized trial designs with high degree of technical success. Likewise, the application of modeling and simulation approaches is extremely valuable in the evaluation of pediatric trial design. Beyond bridging adult dose-exposure relationships, pediatric clinical trial simulation models must accommodate relevant developmental, maturational, and size relationships on both PK and PD expressions. Design considerations that address sample size per age strata, the probability of achieving adult exposure-response targets, and assumptions regarding PD response vs. outcomes are especially valuable in the support of pediatric drug development and/or dosing guidance.

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Authors and Affiliations

  1. Department of Pediatrics, The Children’s Hospital of Philadelphia, Division of Clinical Pharmacology and Therapeutics, University of Pennsylvania Medical School, Philadelphia, PA, USA

    Jeffrey S. Barrett

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  1. Jeffrey S. Barrett
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Correspondence to Jeffrey S. Barrett .

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Editors and Affiliations

  1. Department of Advanced Modeling & Simula, Janssen Research & Development, LLC, Route 202 S. 920, Raritan, 08869, New Jersey, USA

    Holly H. C. Kimko

  2. Dept. Biopharmaceutical Sciences, University of California, San Francisco, Parnassus Ave. 513, San Francisco, 94143-0446, California, USA

    Carl C. Peck

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Barrett, J.S. (2011). Modeling and Simulation in Pediatric Research and Development. In: Kimko, H., Peck, C. (eds) Clinical Trial Simulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 1. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-7415-0_18

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