Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.
Clin Pharmacol Ther. 2015 Sep;98(3):234-7. doi: 10.1002/cpt.163. Epub 2015 Jul 17.
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.
在儿童用药的疗效和安全性方面,仍存在重要的信息空白。儿科药物开发面临着若干伦理、实际和科学方面的挑战。阻碍儿童用药评估的一个障碍是缺乏针对儿童需求而调整的创新方法。本文介绍了我们在欧洲使用 (14) C 标记探针开展儿科微剂量和微示踪研究的成功经验,以说明这些方法的优势和局限性。