Pharmacology Review: Using Modeling and Simulation for Neonatal Drug Development-Reference-Cited by-同舟云学术

Pharmacology Review: Using Modeling and Simulation for Neonatal Drug Development

Published:2015-11-01 Issue:11 Volume:16 Page:e648-e652
ISSN:1526-9906
Container-title:NeoReviews
language:en
Short-container-title:

Author:

Wang Jian¹,Edginton Andrea N.²,Burckart Gilbert¹

Affiliation:

1. Pediatric Clinical Pharmacology Staff, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

2. University of Waterloo, Waterloo, Ontario, Canada.

Abstract

In recent years, there has been an increasing use of modeling and simulation (M&S) within the pharmaceutical industry, along with increasing acceptance of M&S in pediatric drug development by regulatory agencies. Moreover, an increasing body of physiologic, biological, and pharmacologic data has become available to inform neonatal modeling. Developing complementary M&S frameworks for neonates is warranted to support first-in-neonate dose selection and expedite successful neonatal drug development.

Publisher

American Academy of Pediatrics (AAP)

Subject

Pediatrics, Perinatology and Child Health

Link

https://publications.aap.org/neoreviews/article-pdf/16/11/e648/817483/neoreviews_11wang.pdf

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4. Neonatal clinical pharmacology;Allegaert;Paediatr Anaesth,2014

5. Clinical pharmacology in neonates and young infants: the benefit of a population-tailored approach;van den Anker;Expert Rev Clin Pharmacol,2012