Physiologically-Based Pharmacokinetic Modeling to Support Modernized Chemical Safety Assessment
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Owner/Developer: Society of Toxicology (SOT)
United States of America
11 March 2018
United States of America
San Antonio, texas
|Description:||Physiologically-based pharmacokinetic (PBPK) models have been applied to chemical risk assessment for more than three decades. Extrapolation of animal toxicity findings to humans has been the major application of PBPK models in risk assessment. Under the proposed new toxicity testing paradigm, which relies on data from human-relevant in vitro toxicity assays interpreted through computational approaches, PBPK models have been redefined as a critical translation tool for quantitative in vitro to in vivo extrapolation. The models would link effect concentrations in cell-based assays to equivalent human exposures. PBPK models provide a biologically relevant integration platform to describe the absorption, distribution, metabolism, and excretion of chemicals based on a wide range of in vitro, in silico, and, if available, in vivo information. This course will provide an opportunity to revisit the basic principles of PBPK modeling with a special focus on supporting chemical risk assessment under the new toxicity testing paradigm. In addition to describing the basics of model construction, recent advances in model parametrization, including in vitro to in vivo extrapolation and in silico prediction, will be presented. Evaluation of model performance and reliability along with use of available human data will be discussed. Development and application of the PBPK models to support risk-based decisions in different tiers of risk assessment will be presented. A hands-on demonstration will be provided, using a free online simulation tool (PLETHEM) to demonstrate the workflow of building and parameterizing a PBPK model, simulating different human populations, and applying the model to translate concentration-effect relationships from cell-based assays or in vivo studies to the dose-response relationship in target human populations to support chemical risk assessment. The course will address continuing challenges and future directions in PBPK modeling.|
Optional / Voluntary
Professionals (e.g. veterinarians), Scientific officers / Project managers, Managers, Teachers and educators, Regulators and policy-makers, Researchers
SMEs, Consulting, Contract Research Organizations (CROs), Governmental bodies, Industry, Academia
Continuing Professional Development
Full coverage (a dedicated course)
|Details on the topic or technology covered:||
Physiologically-Based Pharmacokinetic Models as a Critical Component in Moving Forward with the New Toxicity Testing Strategies Based on In Vitro and Computational Approaches. Alicia Paini, European Commission Joint Research Centre, Ispra, Italy.
Physiologically-Based Pharmacokinetic Models for Risk and Safety Assessment: Basic Principles and Examples of the Applications in Traditional Risk Assessment. Hugh A. Barton, Pfizer, Inc., Groton, CT.
Parameterization of Physiologically-Based Pharmacokinetic Models with Minimum Reliance on In Vivo Toxicokinetic Studies: Describing Average Person vs. Population. Lisa M. Sweeney, Dayton, OH.
Examples of the Use of Physiologically-Based Pharmacokinetic Models in Support of In Vitro Based Safety Assessment: Hands-On Demonstration of a Work Flow. Miyoung Yoon, ScitoVation, Research Triangle Park, NC.
A Tiered Approach to Incorporate Exposure and Pharmacokinetics Consideration in In Vitro-Based Safety Assessment. Cecilia Tan, US EPA, Research Triangle Park, NC.
Approaches for Evaluation of Non-Animal-Based Physiologically-Based Pharmacokinetic Models Including the Use of Human Biomonitoring Data. Jos Bessems, VITO, Mol, Belgium.
|Accreditation body and/or authority that approved the education or training:||
SOT education program
certificate of attendance
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