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Using the Carcinogenicity Potency Categorization Algorithm to Predict N-Nitrosamine Carcinogenicity

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What is the preferred approach for predicting carcinogenicity potency of N-nitrosamines?

This session will describe the Carcinogenicity Potency Categorization Algorithm (CPCA) that is used by regulators for quickly predicting carcinogenicity potency of N-nitrosamines under ICH M7. The presentation will also make reference to the Health and Environmental Sciences Institute (HESI) nitrosamine QSAR workgroup, where Instem is co-leading a collaboration with health authorities, academics, and industry to address current and future nitrosamine regulatory issues.

This is the concise version of the presentation that was originally shared at the 2024 Annual SOT Meeting and ToxExpo.

Kevin Cross PhD

VP of Regulatory Science