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
Language
- eng
Conference Location
- United States