Pediatric microdose and microtracer studies using 14C in Europe

Important information gaps remain on the efficacy and safety of drugs in children. Pediatric drug development encounters several ethical, practical, and scientific chaflenges One barrier to the evaluation of medicines for children is a lack of Innovative methodologies that have been adapted to the needs of chiIdren This article presents our successful experience of pediatric microdose and microtracer studies using ‘4C-Iabeled probes in Europe to iflustrate the strengths and limitations of these approaches.