2016 SOT FDA Colloquium: Safety Assessment Approaches in Young Children

The Society of Toxicology in conjunction with the US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series. The series presents scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of US FDA employees.

On May 20, 2016, SOT and US FDA co-hosted a colloquium focused on early childhood (from birth to 5 years of age) to examine what those general differences are, provide examples of the differences in this age group, and discuss safety assessment approaches that are being used and proposed.

The first presentation laid the groundwork for this concept and provided an introduction to example case studies that illustrate the importance of safety assessment approaches in early childhood. The second talk focused on pharmacokinetic considerations that provide a mechanistic basis for our assessments. Critical drug metabolism differences underlie many of the measureable differences for children during early childhood. The speaker shared these new observations and resources to find out information about age dependent metabolism differences. Discussions included examples from the neonatal, post birth surge in metabolism capabilities as well as slower trajectory of some metabolism capabilities before reaching adult activities. The third talk provided insight from industry including new models for predicting and modeling responses in early childhood. The current regulatory science behind food safety assessments to protect children during this critical window of susceptibility was the focus of the concluding presentation. Case studies were provided and a panel discussion enhanced interaction with the attendees.