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Literature DB >> 26095095

Pediatric microdose and microtracer studies using 14C in Europe.

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.

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.

Entities: Chemical

Mesh：

Substances：

Year: 2015 PMID： 26095095 DOI： 10.1002/cpt.163

Source DB: PubMed Journal: Clin Pharmacol Ther ISSN： 0009-9236 Impact factor: 6.875

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Cited

15 in total

Review 1. Design and conduct of early phase drug studies in children: challenges and opportunities.

Authors: Michael Rieder; Daniel Hawcutt
Journal: Br J Clin Pharmacol Date: 2016-08-08 Impact factor: 4.335

Review 2. Phase 0/microdosing approaches: time for mainstream application in drug development?

Authors: Tal Burt; Graeme Young; Wooin Lee; Hiroyuki Kusuhara; Oliver Langer; Malcolm Rowland; Yuichi Sugiyama
Journal: Nat Rev Drug Discov Date: 2020-09-08 Impact factor: 84.694

Review 3. Use of Accelerator Mass Spectrometry in Human Health and Molecular Toxicology.

Authors: Heather A Enright; Michael A Malfatti; Maike Zimmermann; Ted Ognibene; Paul Henderson; Kenneth W Turteltaub
Journal: Chem Res Toxicol Date: 2016-10-11 Impact factor: 3.739

4. Successful Use of [¹⁴C]Paracetamol Microdosing to Elucidate Developmental Changes in Drug Metabolism.

Authors: Miriam G Mooij; Esther van Duijn; Catherijne A J Knibbe; Karel Allegaert; Albert D Windhorst; Joost van Rosmalen; N Harry Hendrikse; Dick Tibboel; Wouter H J Vaes; Saskia N de Wildt
Journal: Clin Pharmacokinet Date: 2017-10 Impact factor: 6.447

Review 5. Intra-Target Microdosing (ITM): A Novel Drug Development Approach Aimed at Enabling Safer and Earlier Translation of Biological Insights Into Human Testing.

Authors: T Burt; R J Noveck; D B MacLeod; A T Layton; M Rowland; G Lappin
Journal: Clin Transl Sci Date: 2017-04-18 Impact factor: 4.689

Review 6. Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development.

Authors: T Burt; K Yoshida; G Lappin; L Vuong; C John; S N de Wildt; Y Sugiyama; M Rowland
Journal: Clin Transl Sci Date: 2016-03-30 Impact factor: 4.689

Review 7. Pharmacokinetic studies in children: recommendations for practice and research.

Authors: Charlotte I S Barker; Joseph F Standing; Lauren E Kelly; Lauren Hanly Faught; Allison C Needham; Michael J Rieder; Saskia N de Wildt; Martin Offringa
Journal: Arch Dis Child Date: 2018-04-19 Impact factor: 3.791

Review 8. Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.

Authors: Eva Germovsek; Charlotte I S Barker; Mike Sharland; Joseph F Standing
Journal: Clin Pharmacokinet Date: 2019-01 Impact factor: 5.577

9. Dose-linearity of the pharmacokinetics of an intravenous [¹⁴ C]midazolam microdose in children.

Authors: Bianca D van Groen; Wouter H Vaes; B Kevin Park; Elke H J Krekels; Esther van Duijn; Lenne-Triin Kõrgvee; Wioleta Maruszak; Grzegorz Grynkiewicz; R Colin Garner; Catherijne A J Knibbe; Dick Tibboel; Saskia N de Wildt; Mark A Turner
Journal: Br J Clin Pharmacol Date: 2019-07-30 Impact factor: 4.335

Review 10. Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children.

Authors: Stephen J Balevic; Michael Cohen-Wolkowiez
Journal: J Clin Pharmacol Date: 2018-10 Impact factor: 2.860