title: Applications of accelerator MS in pediatric drug evaluation.
abstract: Accelerator MS (AMS) provides a novel method for obtaining and analyzing pharmacokinetics and pharmacodynamics in children. This paper reviews the scientific and ethical rationale for AMS in pediatric trials, the regulatory framework and general considerations with some specific examples of pediatric clinical trials using AMS. Microdosing in the context of this article refers to studies using a negligible amount (nanocuries) of (14)C as tracer, and AMS as a quantitative technique. The technology is by no means a panacea for the deficiency in pediatric clinical research; however, it lessens the challenges and provides the most quantitative tool for pediatric pharmacology studies.
authors.affiliation: Vitalea Science, Inc., Davis, CA 95618, USA. le@ltvuong.com
authors.forename: L T
authors.initials: LT
authors.lastname: Vuong
authors.forename: A B
authors.initials: AB
authors.lastname: Blood
authors.forename: J S
authors.initials: JS
authors.lastname: Vogel
authors.forename: M E
authors.initials: ME
authors.lastname: Anderson
authors.forename: B
authors.initials: B
authors.lastname: Goldstein
mesh_terms: D000293:Adolescent; D001682:Biological Availability; D002250:Carbon Radioisotopes / Q000032:analysis; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004341:Drug Evaluation / Q000379:methods*; D005060:Europe; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D013058:Mass Spectrometry / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000378:metabolism; D011247:Pregnancy; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D002250:Carbon Radioisotopes; D004364:Pharmaceutical Preparations