New approach methodologies in human regulatory toxicology – Not if, but how and when!

The predominantly animal-centric approach of chemical safety assessment has increasingly come under pressure. Society is questioning overall performance, sustainability, continued relevance for human health risk assessment and ethics of this system, demanding a change of paradigm. At the same time, the scientific toolbox used for risk assessment is continuously enriched by the development of "New Approach Methodologies" (NAMs). While this term does not define the age or the state of readiness of the innovation, it covers a wide range of methods, including quantitative structure-activity relationship (QSAR) predictions, high-throughput screening (HTS) bioassays, omics applications, cell cultures, organoids,…

• UE
  U.S. Environmental Protection Agency
• WH
  World Health Organization
• EF
  European Food Safety Authority
• UD
  Universität des Saarlandes
• NI
  National Institutes of Health
• UF
  U.S. Food and Drug Administration
• HC
  Health Canada
• DF
  Directorate-General for the Environment
• JR
  Joint Research Centre
• NC
  National Center for Advancing Translational Sciences