Pediatric microdose and microtracer studies using 14C in Europe

M A Turner; M G Mooij; W H J Vaes; A D Windhorst; N H Hendrikse; C A J Knibbe; L T Kõrgvee; W Maruszak; G Grynkiewicz; R C Garner; D Tibboel; B K Park; S N de Wildt

doi:10.1002/cpt.163

Pediatric microdose and microtracer studies using 14C in Europe

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

Authors

M A Turner¹, M G Mooij², W H J Vaes³, A D Windhorst⁴, N H Hendrikse⁵, C A J Knibbe^{6

7}, L T Kõrgvee⁸, W Maruszak⁹, G Grynkiewicz¹⁰, R C Garner¹¹, D Tibboel², B K Park¹², S N de Wildt²

Affiliations

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.

PMID: 26095095
DOI: 10.1002/cpt.163

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

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

Substances

Carbon Radioisotopes
Pharmaceutical Preparations

Abstract

Publication types

MeSH terms

Substances

Grants and funding