Print Email Facebook Twitter Pediatric Mïcrodose and Microtracer Studies Using 14C in Europe Title Pediatric Mïcrodose and Microtracer Studies Using 14C in Europe 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. de Wildt, S.N. Publication year 2015 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. Subject LifeMSB - Microbiology and Systems BiologyELSS - Earth, Life and Social SciencesFood and NutritionNutritionHealthy LivingCarbonDrugAgeDose calculationDose responseDrug-Related Side Effects and Adverse ReactionsEconomicsEthicsLegislation and jurisprudenceMetabolismNewbornPhase 1 clinical trial (topic)Preschool childAge FactorsCarbon RadioisotopesChildChild, PreschoolClinical Trials, Phase I as TopicDose-Response Relationship, DrugDrug ApprovalDrug CostsDrug Dosage CalculationsDrug-Related Side Effects and Adverse ReactionsEuropeGovernment RegulationHumansInfantInfant, NewbornPatient SafetyPharmaceutical PreparationsPharmacokineticsRisk AssessmentRisk Factors To reference this document use: http://resolver.tudelft.nl/uuid:26814d1b-b57f-4021-9a19-2020ad1092b5 TNO identifier 528505 Source Clinical Pharmacology & Therapeutics, 98 (3), 234-237 Document type article Files To receive the publication files, please send an e-mail request to TNO Library.