2015 SOT FDA Colloquium: Application of ADME/PK Studies to Improve Safety Assessments for Foods and Cosmetics—February 23, 2015

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 February 23, 2015, SOT and US FDA co-hosted a colloquium focused on the application of ADME/PK studies to improve safety assessments for foods and cosmetics. This colloquium provided a synopsis of the current state of the art for the application of pharmacokinetic data and modeling to risk assessments for foods, food contaminants and cosmetic ingredients. Three case studies were provided illustrating the process of incorporating pharmacokinetic data in risk assessments based either on traditional or emerging toxicity study approaches. A panel discussion enhanced interaction with the attendees.

Pharmacokinetic data on the time-course of a chemical in the body can be used to support the key extrapolations that are typically necessary for chemical risk assessments. In the past, the primary concern has been to extrapolate the doses in animal studies showing effects to equivalent doses in the human. With the recent emphasis on in vitro-based risk assessment, pharmacokinetic information is now being used to support the extrapolation from media concentrations associated with effects in vitro to the equivalent in vivo dose.