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  1. Paper

    Ames Concordance with the In Vivo Transgenic Rodent (TGR) Gene Mutation Assay for NDSRIs and Relative In Vivo TGR Potency with Nitrosamines with Robust Dose-Response Carcinogenicity Data

    • Feb 2026
    • Carcinogenicity assessment, Nitrosamine impurity risk assessment

  2. Paper

    Establishing Best Practice for N-Nitrosamine Read-Across and Surrogate Selection

    • Dec 2025
    • AI/PDE, Complex Nitrosamines, Nitrosamine impurity risk assessment, Safety profiling in drug discovery

  3. Paper

    Development of a Skin Sensitization Site-of-Contact Exposure Threshold (SoCET) for Botanicals and Natural Substances

    • Nov 2025
    • Skin sensitisation assessment

  4. Paper

    Evaluating the ability of defined approaches to predict the human skin sensitisation potential of chemicals previously untested in new approach methodologies

    • Nov 2025
    • Skin sensitisation assessment

  5. Paper

    Computational mechanistic study on N-nitrosation reaction of secondary amines

    • Oct 2025
    • Nitrosamine impurity risk assessment

  6. Poster

    Using an AOP framework to identify the most human-relevant test species – for confident single-species DART assessments

    • Sep 2025
    • Safety profiling in drug discovery

  7. Paper

    Nitrite testing in excipients – Industry best practices

    • Aug 2025
    • Nitrites

  8. Poster

    Can the Second Species Be Replaced by an Adverse Outcome Pathway-Based In Silico Model?

    • Aug 2025
    • Carcinogenicity assessment, Safety profiling in drug discovery

  9. Paper

    Evaluating the Lifetime Cumulative Dose as a Basis for Carcinogenic potency of Nitrosamines

    • Jul 2025
    • Carcinogenicity assessment

  10. Paper

    Drug Substance and Drug Product Workflows for Quality Risk Management for the Presence of Nitrosamines in Medicines

    • May 2025
    • Nitrosamine impurity risk assessment

  11. Paper

    HESI GTTC Ring Trial: Concordance between Ames and Rodent Carcinogenicity Outcomes for N-Nitrosamines (NAs) with Rat and Hamster Metabolic Conditions

    • May 2025
    • Carcinogenicity assessment, Nitrosamine impurity risk assessment

  12. Infographic

    How to overcome the critical challenges faced in forced degradation studies

    • Mar 2025
    • Impurity and degradant control