title: Pediatric microdose and microtracer studies using 14C in Europe.
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.
authors.affiliation: Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
authors.forename: M A
authors.initials: MA
authors.lastname: Turner
authors.affiliation: Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.
authors.forename: M G
authors.initials: MG
authors.lastname: Mooij
authors.affiliation: TNO, Zeist, The Netherlands.
authors.forename: W H J
authors.initials: WH
authors.lastname: Vaes
authors.affiliation: Department of Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: A D
authors.initials: AD
authors.lastname: Windhorst
authors.affiliation: Department of Clinical Pharmacology & Pharmacy, Department of Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: N H
authors.initials: NH
authors.lastname: Hendrikse
authors.affiliation: Faculty of Science, Leiden Academic Centre for Research, Pharmacology, Leiden, The Netherlands.|Hospital Pharmacy and Clinical Pharmacology, St. Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: C A J
authors.initials: CA
authors.lastname: Knibbe
authors.affiliation: Department of Clinical Pharmacology, University of Tartu, Tartu, Estonia.
authors.forename: L T
authors.initials: LT
authors.lastname: Kõrgvee
authors.affiliation: R&D Analytical Chemistry Department, Pharmaceutical Research Institute, Warsaw, Poland.
authors.forename: W
authors.initials: W
authors.lastname: Maruszak
authors.affiliation: Pharmaceutical Research Institute, Warsaw, Poland.
authors.forename: G
authors.initials: G
authors.lastname: Grynkiewicz
authors.affiliation: Garner Consulting and Hull York Medical School, University of York, York, UK.
authors.forename: R C
authors.initials: RC
authors.lastname: Garner
authors.affiliation: Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.
authors.forename: D
authors.initials: D
authors.lastname: Tibboel
authors.affiliation: Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
authors.forename: B K
authors.initials: BK
authors.lastname: Park
authors.affiliation: Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.
authors.forename: S N
authors.initials: SN
authors.lastname: de Wildt
mesh_terms: D000367:Age Factors; D002250:Carbon Radioisotopes / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics / Q000493:pharmacokinetics; D002648:Child; D002675:Child, Preschool; D017321:Clinical Trials, Phase I as Topic / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D016527:Drug Costs; D054796:Drug Dosage Calculations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology / Q000517:prevention & control; D005060:Europe; D033161:Government Regulation; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000191:economics / Q000378:metabolism; D010599:Pharmacokinetics; D018570:Risk Assessment; D012307:Risk Factors
chemical_list: D002250:Carbon Radioisotopes; D004364:Pharmaceutical Preparations