Proprietary Modeling Platforms: A Shaky Platform for Risk Assessments and Regulatory Decisions?

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Propriety modeling (PM) platforms that facilitate PBPK and QSAR modeling are increasingly used in risk assessments supporting regulatory decisions. These platforms are supported by datasets and source code that undergo limited independent verification or validation, leading PM detractors to liken PM software to a “black box.” Wednesday’s Roundtable at the SOT 58th Annual Meeting and ToxExpo titled “A Multi-Stakeholder Dialogue on Using Proprietary Modeling Platforms to Support Risk Assessment and Regulatory Decisions” brought developers, academics, and regulators from the United States and Canada together to discuss and dispel some of the myths associated with PM platforms.

From Health Canada’s perspective, PBPK modeling facilitates improved prediction of exposure in specific subpopulations and improves interspecies, interindividual, and route-to-route extrapolations. Sami Haddad of the University of Montreal conceded that PM offers convenience for novice PBPK modelers. However, high PM platform cost and lack of access to source code limit the utility of PM platforms to train the next generation of PBPK modelers. Widespread use of PM platforms to support regulatory decisions is unlikely to occur until the “black box” underlying PM platforms transforms to one that exhibits greater transparency.

This blog was prepared by an SOT Reporter. SOT Reporters are SOT members who volunteer to write about sessions and events they attend during the SOT Annual Meeting and ToxExpo. If you are interested in participating in the SOT Reporter program in the future, please email Giuliana Macaluso.

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