February 17–18, 2016

In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making

In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making Final Documents

February 17–18, 2016

• Workshop Report (Toxicology In Vitro)

In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making Meeting Materials

February 17–18, 2016

• Presentation Abstracts
• Breakout Group Questions
• Poster Abstracts
• Speaker Biographies

In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making Presentations

February 17–18, 2016

Workshop Presentations

Opening Session

• Welcome
  Warren Casey, NIEHS/NICEATM
• The EURL ECVAM Toxicokinetics Report and EURL ECVAM Strategy
  Alicia Paini, European Union Reference Laboratory for Alternatives to Animal Testing
• Workshop Background and Summaries of Webinars
  John Wambaugh, U.S. Environmental Protection Agency (EPA)

Session 1: Application in Risk Assessment: What Do We Need for Decision-making and Prioritization?

• Using In Vitro Data in Quantitative Risk Assessments (QRAs)
  Paul Price, EPA
• Interindividual Variability in High Throughput Risk Prioritization of Environmental Chemicals
  Caroline Ring, EPA
• Quantitative Considerations of Dose-Response for IVIVE
  Ted Simon, Ted Simon LLC
• Toxicokinetics in Risk Assessment: From Predictive Evaluations to Regulatory Testing
  Mike Bartels, The Dow Chemical Company
• Development and Application of Biologically Based Dose-Response Modeling for Pregnancy Conditions: Evaluation of Thyroid Active Chemical Exposure During Sensitive Life Stages
  Annie Lumen, U.S. Food and Drug Administration

Session 2: Metabolism and Excretion

• Strength and Limitations of In Vitro Xenobiotic Metabolism Assays and In Silico Models
  Stephen Ferguson, NIEHS
• In Silico Screening of Primary Clearance Mechanisms
  John Troutman, The Procter & Gamble Company
• In Vitro Models for Quantitative Prediction of Hepatobiliary Clearance
  Kim Brouwer, University of North Carolina at Chapel Hill

Session 3: In Silico Modeling

• Predictive Power of PBPK Modeling and In Silico/In Vitro-In Vivo Extrapolation Using GastroPlus™ and ADMET Predictor™ Software Tools
  Grazyna Fraczkiewicz, Simulations Plus, Inc.
• In Vitro In Vivo Extrapolation and its Applications in Predicting Pharmacokinetic Population Variability
  Alice Ke, SimCyp, a Certara Company

Summary Presentations

• Day 1 Wrap-up
  Barbara Wetmore, ScitoVation, LLC
• Breakout Group Summary

Webinar Materials

October 7: Setting the Stage: Purpose, Definitions, Scope, and Assumptions

Barbara Wetmore, Ph.D., The Hamner Institutes for Health Sciences

• October webinar slides
• Wetmore bio

November 4: Building Fit-for-purpose Pharmacokinetic Models

John Wambaugh, Ph.D., National Center for Computational Toxicology, U.S. Environmental Protection Agency

• November webinar slides
• Wambaugh bio

December 3: The Role of Pharmacokinetic Model Evaluation

Lisa Sweeney, Ph.D., Naval Medical Research Unit Dayton and Jackson Foundation for the Advancement of Military Medicine

• December webinar slides
• December webinar abstract
• Sweeney bio

January 6: Framework for Establishing an Internal Threshold of Toxicological Concern

Corie Ellison, Ph.D., Sharon Woods Innovation Center, The Procter & Gamble Company

• January webinar slides
• January webinar abstract
• Ellison bio