Microdosing Studies in Children: A US Regulatory Perspective

M Roth-Cline; R M Nelson

doi:10.1002/cpt.165

Microdosing Studies in Children: A US Regulatory Perspective

Clin Pharmacol Ther. 2015 Sep;98(3):232-3. doi: 10.1002/cpt.165. Epub 2015 Jul 14.

Authors

M Roth-Cline¹, R M Nelson¹

Affiliation

¹ Office of Pediatric Therapeutics, FDA, Silver Spring, Maryland, USA.

PMID: 26095312
DOI: 10.1002/cpt.165

Abstract

Microdosing studies in children are used to obtain pharmacokinetic information, to study the ontogeny of metabolic enzymes, or to study drug disposition.

Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

MeSH terms

Age Factors
Child
Child, Preschool
Clinical Trials, Phase I as Topic / legislation & jurisprudence*
Drug Approval / legislation & jurisprudence*
Drug Dosage Calculations
Drug-Related Side Effects and Adverse Reactions / etiology
Drug-Related Side Effects and Adverse Reactions / prevention & control
Government Regulation*
Humans
Infant
Infant, Newborn
Patient Safety
Pharmaceutical Preparations / administration & dosage*
Pharmaceutical Preparations / metabolism
Pharmacokinetics
Risk Assessment
Risk Factors
United States
United States Food and Drug Administration / legislation & jurisprudence*

Substances

Pharmaceutical Preparations