In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making Final Documents
February 17–18, 2016
Federal Register Notices February 17–18, 2016
In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making Meeting Materials
February 17–18, 2016
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
November 4: Building Fit-for-purpose Pharmacokinetic Models
John Wambaugh, Ph.D., National Center for Computational Toxicology, U.S. Environmental Protection Agency
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
January 6: Framework for Establishing an Internal Threshold of Toxicological Concern
Corie Ellison, Ph.D., Sharon Woods Innovation Center, The Procter & Gamble Company