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Physiologically-based kinetic modelling in risk assessment
Citation:
Tan, C. AND A. Paini. Physiologically-based kinetic modelling in risk assessment. 2017 ISES Annual Meeting, Research Triangle Park, NC, October 15 - 19, 2017.
Impact/Purpose:
The EURL ECVAM strategy document on Toxicokinetics (TK) outlines PBK models as a central feature for their potential use to integrate data generated by in vitro and in silico methods for absorption, distribution, metabolism, and excretion (ADME) in humans and to predict whole-body biokinetic behaviors. The presentation will also show results from an international survey on application of PBK models in science and regulatory submission. Analysis of the survey data will provide insights into key concerns in the PBK modeling community, so that recommendations can be made to promote the development and acceptance of PBK models in the safety assessment of chemicals.
Description:
The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) hosted a two-day workshop with an aim to discuss the role and application of Physiologically Based Kinetic (PBK) models in regulatory decision making. The EURL ECVAM strategy document on Toxicokinetics (TK) outlines PBK models as a central feature for their potential use to integrate data generated by in vitro and in silico methods for absorption, distribution, metabolism, and excretion (ADME) in humans and to predict whole-body biokinetic behaviors. Experts were invited to identify, discuss and recommend challenges in application of PBK models to support regulatory risk assessment. The two primary challenges were i) constructing models that rely on in vitro and in silico methods for parameterization; (ii) assessing model credibility when in vivo kinetic data are not available for model evaluation how to validated or calibrated models with non-animal data. To address these challenges, the experts recommended a best practices workflow for guidance on the use of in vitro and in silico data in PBK models designed to support regulatory decision making. The outcomes of the workshop and recommendations of the experts will be summarized in this presentation. The presentation will also show results from an international survey on application of PBK models in science and regulatory submission. Analysis of the survey data will provide insights into key concerns in the PBK modeling community, so that recommendations can be made to promote the development and acceptance of PBK models in the safety assessment of chemicals. Disclaimer: This abstract has been cleared by the EPA but solely expresses the view of the author.
