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
Life
MSB - Microbiology and Systems Biology
ELSS - Earth, Life and Social Sciences
Food and Nutrition
Nutrition
Healthy Living
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
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