Dosing in neonates: special considerations in physiology and trial design.

Journal Article (Journal Article;Review)

Determining the right dose for drugs used to treat neonates is critically important. Neonates have significant differences in physiology affecting drug absorption, distribution, metabolism, and elimination that make extrapolating dosages from adults and older children inappropriate. In spite of recent legislative efforts requiring drug studies in this population, most drugs given to neonates remain insufficiently studied. Many ethical and logistical concerns make designing studies in this age group difficult. Fortunately, specialized analytical techniques, such as the use of dried blood spots, scavenged sampling, population pharmacokinetics analyses, and sparse sampling, have helped investigators better define doses that maximize efficacy and safety. Through the use of these methods, successful clinical trials have resulted in recent changes to drug dosing in this population.

Full Text

Duke Authors

Cited Authors

  • Ku, LC; Smith, PB

Published Date

  • January 2015

Published In

Volume / Issue

  • 77 / 1-1

Start / End Page

  • 2 - 9

PubMed ID

  • 25268145

Pubmed Central ID

  • 25268145

Electronic International Standard Serial Number (EISSN)

  • 1530-0447

Digital Object Identifier (DOI)

  • 10.1038/pr.2014.143


  • eng

Conference Location

  • United States