• Elena Fioravanzo

from the SOT FDA colloquia in May ...

Updated: Jul 12, 2019

Prof. Jim Rathman talked of "Identifying, Estimating, and Communicating Uncertainty in In Silico Approaches to Chemical Safety Assessment" at the SOT and US FDA Center for Food Safety and Applied Nutrition (CFSAN) colloquia in May.

The recordings of the colloquia will be available soon, but you can already download the presentations.

Chair: Kirk Arvidson, US FDA, College Park, MD Co-chair: Chihae Yang, MN AM, Nurnberg, Germany


This colloquium will feature the science behind new international trends in the in silico safety assessment of chemical exposure. Two common themes shared by international regulatory bodies are the critical issues involved in alternative methods to animal testing and the rigorous treatment of uncertainties to obtain reproducible and transparent weight-of-evidence approaches to decision making. For alternative methods to repeated-dose toxicity, toxicokinetics and metabolism are emphasized to understand chemical exposure and bioavailability. Biokinetics is further being applied to data-waiving methods such as the Threshold of Toxicological Concerns (TTC). Internal TTC is a TTC concept for situations of low internal exposure, where this value is more relevant than the external exposure. Development of internal TTCs requires a significant amount of data and computational tools (e.g., PBPK modeling) to convert the chemical specific external doses (i.e., NOAELs) in the TTC databases into an estimate of the internal exposure. The common concerns related to the relevance of in silico chemical safety assessment that may hinder its adoption if not properly addressed will be discussed.

Colloquium Materials

Agenda | Event Captions (not available) | Video Presentation (pending)

Presentation Slides

Welcome and Overview Suzanne Fitzpatrick, US FDA, CFSAN, College Park, MD Speaker Introductions Kirk Arvidson, US FDA, College Park, MD

Drivers for the Application and Acceptance ofIn Silico Safety Assessment Based on Chemical Exposure Mark Cronin, Liverpool John Moores University, Liverpool, UK

Current Issues of Uncertainty in In Silico Methods James F. Rathman, The Ohio State University, Columbus, OH

A Case Study on PBPK and Biologically Based Dose-Response Modeling for Safety Assessment Considerations: Utility and Challenges Annie Lumen, NCTR, Jefferson, AR

Transformation of Threshold of Toxicological Concerns (TTC) to Internal TTC: Why Internal Exposure Matters and How We Will Get There Corie Ellison, Procter and Gamble, West Chester, OH

Concluding Slides Roundtable Discussion Moderators: Kirk Arvidson, US FDA, College Park, MD, and Chihae Yang, MN AM, Nurnberg, Germany All Speakers

Organizing Committee

  • Allen Rudman, PhD, Colloquium Series Chair, US FDA, College Park, MD

  • Jia-Sheng Wang, MD, PhD, Colloquium Series Co-Chair University of Georgia, Athens, GA

  • Jason L. Aungst, PhD, US FDA, College Park, MD

  • Suzanne Compton Fitzpatrick, PhD, DABT, Member, Colloquium Chair, US FDA, College Park, MD

  • Wallace Hayes, PhD, DABT, ERT, ATS, FRSB, FACFE, University of South Florida and Michigan State University, Temple Terrace, FL

  • Jieun Lee, PhD, DABT, Kellogg, Battle Creek, MI

  • Stephen M. Roberts, PhD, University of Florida, Gainesville, FLJeffrey J. Yourick, PhD, DABT, ATS, US FDA, Laurel, MD

  • Anne Chappelle, Council Contact, Chadds Ford, PA

  • Betty Eidemiller, PhD, SOT Staff, Reston, VA