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

The scientific toolbox used for risk assessment is continuously enriched by the development of New Approach Methods (NAMs). While this term does not define the age or the state of readiness of the innovation, it covers a wide range of methods. This article intends to provide further insights into how NAMs can be gradually integrated into chemical risk assessment aimed at protection of human health, until eventually the current paradigm is replaced by an animal-free “Next Generation Risk Assessment” (NGRA).ologies” (NAMs). The conceptual perspective presented in this article has its focus on hazard assessment and is grounded on the main findings and conclusions from a symposium and workshop held in Berlin in November 2021.

The article was published in the journal Environment International.

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

Sebastian Schmeisser, Andrea Miccoli, Martin von Bergen, Elisabet Berggren, Albert Braeuning, Wibke Busch, Christian Desaintes, Anne Gourmelon, Roland Grafström, Joshua Harrill, Thomas Hartung, Matthias Herzler, George E.N. Kass, Nicole Kleinstreuer, Marcel Leist, Mirjam Luijten, Philip Marx-Stoelting, Oliver Poetz, Bennard van Ravenzwaay, Rob Roggeband, Vera Rogiers, Adrian Roth, Pascal Sanders, Russell S. Thomas, Anne Marie Vinggaard, Mathieu Vinken, Bob van de Water, Andreas Luch, Tewes Tralau

Environment International,
Volume 178, 2023, 108082,




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