title: Microdosing Studies in Children: A US Regulatory Perspective.
abstract: Microdosing studies in children are used to obtain pharmacokinetic information, to study the ontogeny of metabolic enzymes, or to study drug disposition.
authors.affiliation: Office of Pediatric Therapeutics, FDA, Silver Spring, Maryland, USA.
authors.forename: M
authors.initials: M
authors.lastname: Roth-Cline
authors.affiliation: Office of Pediatric Therapeutics, FDA, Silver Spring, Maryland, USA.
authors.forename: R M
authors.initials: RM
authors.lastname: Nelson
mesh_terms: D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D017321:Clinical Trials, Phase I as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D054796:Drug Dosage Calculations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology / Q000517:prevention & control; D033161:Government Regulation; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000378:metabolism; D010599:Pharmacokinetics; D018570:Risk Assessment; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D004364:Pharmaceutical Preparations