Application of In Vitro to In Vivo Extrapolation in Safety Assessment

Description

SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety. December 1, 2016 - Application of In Vitro to In Vivo Extrapolation in Safety Assessment. The webcast of the upcoming colloquium will provide an overview of In Vitro to In Vivo Extrapolation (IVIVE) including potential application to evaluation of food safety as well as future challenges. IVIVE is a technique that uses knowledge (or measurements) of chemical specific distribution parameters and physiologically-based pharmacokinetic modeling to calculate oral equivalent doses (or internal circulating/target organ concentrations) in humans. Such IVIVE-derived doses can then be compared to modeled or measured human intakes or exposures to better understand margins of exposure. With accelerating use of in vitro methods such as advanced high throughput screening methods and high content cellular based omics to examine potential effects of consumer product chemicals, commodity substances, food additives and ingredients, IVIVE is an important tool. Application of In Vitro to In Vivo Extrapolation in Safety Assessment December 1, 2016 8:30 AM–12:50 PM ET (GMT-5) Wiley Auditorium, US FDA, College Park, Maryland Register to participate in the webcast Colloquium website The SOT FDA Food Safety Colloquia present scientific training that is high quality, cutting-edge, future-oriented toxicological science for US FDA employees and are open to the public at no cost. However, the colloquia are not a public forum for discussion of toxicology regulatory issues. Presentations include: • Overview and Principles Underpinning In Vitro to In Vivo Extrapolation, Lisa M. Sweeney, Naval Medical Research Unit Dayton, Dayton, OH • Data Needed and Specific Steps Required for Developing and Verifying IVIVE Models, Nynke Kramer, Utrecht University, Netherlands • Examples Illustrating Potential Applications of IVIVE in Chemical Assessment, Miyoung Yoon, ScitoVation, Research Triangle Park, NC • Opportunities and Challenges for Using IVIVE to Improve Decision Making, Weihsueh Chiu, Texas A&M University, College Station, TX The speakers will conclude the event with a roundtable discussion moderated by colloquium chair Richard Becker, American Chemistry Council, Washington, DC. Questions from the audience on-site and from those participating in the webcast are encouraged. Lisa Sweeney, Naval Medical Research Unit Dayton, Dayton, OH, is the co-chair of this colloquium. Recordings and slides from the previous colloquia are available free via the SOT FDA Colloquia website, including the most recent session, the October 12 “State of the Science Supporting Regulatory Decision-Making in Developmental Neurotoxicology.”

Period	1 Dec 2016
Held at	American Society of Toxicology (SOT). , United States