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What have we been up to
From evidence synthesis and regulatory toxicology to human-relevant approaches, we work on projects that address current challenges in toxicology. Explore what we have been working on, what we have learned, and how our work contributes to more evidence-based and human-relevant toxicology.
Topic: Human-Relevant NAMs for Assessing Developmental Neurotoxicity (DNT) in Human
Developmental neurotoxicity (DNT) assessment remains largely dependent on animal-based approaches, despite their ethical, practical, and translational limitations. The growing need for high-throughput, cost-effective, and human-relevant approaches has therefore driven increasing interest in new approach methodologies (NAMs), including human stem cell- and organoid-based models.
Topic: Animal-Model Limitations and NAM Opportunities for Nonclinical Assessment of Antibody Therapies
Antibody therapeutics have transformed the treatment of cancer, autoimmune, and infectious diseases, but their species-specific mechanisms can pose significant challenges for conventional animal-based nonclinical assessment. Documented translational limitations, together with the growing regulatory momentum toward reducing animal testing, have increased interest in human-relevant new approach methodologies (NAMs)
Topic: NAM Alternatives for Assessment of Nitrosamines Impurities in Drug Manufacturing
Nitrosamine impurities have emerged as a major challenge in pharmaceutical manufacturing, raising significant public health and regulatory concerns due to their potential carcinogenicity. Although ICH M7(R2) promotes the use of non-animal approaches such as the Ames test, literature-based assessment, and computational models, in vivo gene mutation assays may still be recommended for confirmatory purposes when impurity levels cannot be adequately controlled.