Dosing in neonates: special considerations in physiology and trial design.
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.
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Related Subject Headings
- Treatment Outcome
- Research Design
- Pharmaceutical Preparations
- Pediatrics
- Pediatrics
- Infant, Newborn
- Humans
- Glomerular Filtration Rate
- Fluconazole
- Drug Dosage Calculations
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Treatment Outcome
- Research Design
- Pharmaceutical Preparations
- Pediatrics
- Pediatrics
- Infant, Newborn
- Humans
- Glomerular Filtration Rate
- Fluconazole
- Drug Dosage Calculations