2016 SOT FDA Colloquium: Application of In Vitro to In Vivo Extrapolation in Safety Assessment

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 December 1, 2016, SOT and US FDA co-hosted a colloquium focused on the "Application of In Vitro to In Vivo Extrapolation in Safety Assessment."

The colloquium started with an overview of IVIVE and a discussion of the principles underpinning the development of the methodology and highlight key elements to think through when considering applying IVIVE. Second, technical details and data needed for IVIVE were discussed. Third, examples of IVIVE applications in chemical assessment (including substances relevant to food safety) were presented. Fourth, the opportunities and challenges for using IVIVE in safety evaluations were discussed. Finally, the colloquium concluded with a panel discussion addressing the key issues brought up by the speakers and questions from participants.