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Clin Pharmacol Ther. 2015 Sep;98(3):234-7. doi: 10.1002/cpt.163. Epub 2015 Jul 17.

Pediatric microdose and microtracer studies using 14C in Europe.

Author information

1
Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
2
Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.
3
TNO, Zeist, The Netherlands.
4
Department of Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.
5
Department of Clinical Pharmacology & Pharmacy, Department of Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.
6
Faculty of Science, Leiden Academic Centre for Research, Pharmacology, Leiden, The Netherlands.
7
Hospital Pharmacy and Clinical Pharmacology, St. Antonius Hospital, Nieuwegein, The Netherlands.
8
Department of Clinical Pharmacology, University of Tartu, Tartu, Estonia.
9
R&D Analytical Chemistry Department, Pharmaceutical Research Institute, Warsaw, Poland.
10
Pharmaceutical Research Institute, Warsaw, Poland.
11
Garner Consulting and Hull York Medical School, University of York, York, UK.
12
Institute of Translational Medicine, University of Liverpool, Liverpool, UK.

Abstract

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.

PMID:
26095095
DOI:
10.1002/cpt.163
[Indexed for MEDLINE]

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