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Pediatric Age Groups and Approach to Studies

  • Special Section: Pediatric Therapeutic Development: Commentary
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Abstract

Pediatric clinical trials are often requested according to specific age ranges. In the past and still today, these ages may correspond to developmental stages, such as newborn, infancy, childhood, and adolescence. Selection of ages for pediatric participation in medication studies should correspond to ages of rapid changes in pharmacokinetics and pharmacodynamics. Age-related changes in several enzymes involved in drug metabolism and glomerular filtration are described as examples of optimal ages for study of specific drugs according to their pathways of disposition.

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Authors and Affiliations

  1. Division of Clinical Pharmacology, Department of Pediatrics, University of Utah, 295 S Chipeta Way 1S100, Salt Lake City, UT, 84108, USA

    Kathleen M. Job PhD & Robert M. Ward MD

  2. Global Statistical Sciences, Eli Lilly and Co, Indianapolis, IN, USA

    Margaret Gamalo PhD

Authors
  1. Kathleen M. Job PhD
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  2. Margaret Gamalo PhD
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  3. Robert M. Ward MD
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Correspondence to Kathleen M. Job PhD.

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Job, K.M., Gamalo, M. & Ward, R.M. Pediatric Age Groups and Approach to Studies. Ther Innov Regul Sci 53, 584–589 (2019). https://doi.org/10.1177/2168479019856572

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  • DOI: https://doi.org/10.1177/2168479019856572

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