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Pediatric Mïcrodose and Microtracer Studies Using 14C in Europe

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Author: Turner, M.A. · Mooij, M.G. · Vaes, W.H.J. · Windhorst, A.D. · Hendrikse, N.H. · Knibbe, C.A.J. · Körgvee, L.T. · Maruszak, W. · Grynkiewicz, G. · Garner, R.C. · Tibbocl, D. · Park, B.K. · Wildt, S.N. de
Type:article
Date:2015
Source:Clinical Pharmacology & Therapeutics, 3, 98, 234-237
Identifier: 528505
Keywords: Nutrition · Carbon · Drug · Age · Dose calculation · Dose response · Drug-Related Side Effects and Adverse Reactions · Economics · Ethics · Legislation and jurisprudence · Metabolism · Newborn · Phase 1 clinical trial (topic) · Preschool child · Age Factors · Carbon Radioisotopes · Child · Child, Preschool · Clinical Trials, Phase I as Topic · Dose-Response Relationship, Drug · Drug Approval · Drug Costs · Drug Dosage Calculations · Drug-Related Side Effects and Adverse Reactions · Europe · Government Regulation · Humans · Infant · Infant, Newborn · Patient Safety · Pharmaceutical Preparations · Pharmacokinetics · Risk Assessment · Risk Factors · Food and Nutrition · Healthy Living · Life · MSB - Microbiology and Systems Biology · ELSS - Earth, Life and Social Sciences

Abstract

Important information gaps remain on the efficacy and safety of drugs in children. Pediatric drug development encounters several ethical, practical, and scientifîc chaflenges One barrier to the evaluation of medicines for children is a lack of Innovative methodologies that have been adapted to the needs of chiIdren This article presents our successful experience of pediatric microdose and microtracer studies using ‘4C-Iabeled probes in Europe to iflustrate the strengths and limitations of these approaches.