Microdosing Studies in Children: A US Regulatory Perspective

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

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2015-09, Vol.98 (3), p.232-233
Main Authors: Roth-Cline, M, Nelson, RM
Format: Article
Language:English
Subjects:
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
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Description
Summary:Microdosing studies in children are used to obtain pharmacokinetic information, to study the ontogeny of metabolic enzymes, or to study drug disposition.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.165