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