Pediatric microdose and microtracer studies using 14C in Europe

• Published in: Clinical pharmacology and therapeutics Vol. 98; no. 3; p. 234
• Main Authors: Turner, M A, Mooij, M G, Vaes, W H J, Windhorst, A D, Hendrikse, N H, Knibbe, C A J, Kõrgvee, L T, Maruszak, W, Grynkiewicz, G, Garner, R C, Tibboel, D, Park, B K, de Wildt, S N
• Format: Journal Article
• Language: English
• Published: United States 01.09.2015
• Subjects: Age Factors; Carbon Radioisotopes - administration & dosage; Carbon Radioisotopes - adverse effects; Carbon Radioisotopes - economics; Carbon Radioisotopes - pharmacokinetics; Child; Child, Preschool; Clinical Trials, Phase I as Topic - economics; Clinical Trials, Phase I as Topic - ethics; Clinical Trials, Phase I as Topic - legislation & jurisprudence; Dose-Response Relationship, Drug; Drug Approval - economics; Drug Approval - legislation & jurisprudence; Drug Costs; Drug Dosage Calculations; Drug-Related Side Effects and Adverse Reactions - etiology; Drug-Related Side Effects and Adverse Reactions - prevention & control; Europe; Government Regulation; Humans; Infant; Infant, Newborn; Patient Safety; Pharmaceutical Preparations - administration & dosage; Pharmaceutical Preparations - economics; Pharmaceutical Preparations - metabolism; Pharmacokinetics; Risk Assessment; Risk Factors; Europe
• ISSN: 1532-6535
• DOI: 10.1002/cpt.163

Important information gaps remain on the efficacy and safety of drugs in children. Pediatric drug development encounters several ethical, practical, and scientific challenges. One barrier to the evaluation of medicines for children is a lack of innovative methodologies that have been adapted to the needs of children. This article presents our successful experience of pediatric microdose and microtracer studies using (14) C-labeled probes in Europe to illustrate the strengths and limitations of these approaches.