title: Dosing in neonates: special considerations in physiology and trial design.
abstract: 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.
authors.affiliation: Department of Pediatrics, Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Lawrence C
authors.initials: LC
authors.lastname: Ku
authors.affiliation: Department of Pediatrics, Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: P Brian
authors.initials: PB
authors.lastname: Smith
mesh_terms: D000818:Animals; D000890:Anti-Infective Agents / Q000008:administration & dosage; D002986:Clinical Trials as Topic; D015195:Drug Design; D054796:Drug Dosage Calculations; D015725:Fluconazole / Q000008:administration & dosage; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007231:Infant, Newborn; D010372:Pediatrics / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000737:chemistry; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D004364:Pharmaceutical Preparations; D015725:Fluconazole