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Sebastian Schmeisser, Andrea Miccoli, Martin von Bergen�, Elisabet Berggren, Albert Braeuning, Wibke Busch, Christian Desaintes, Anne Gourmelon, Roland Grafström, Joshua Harrill and 19 more
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, microphysiological systems (MPS), machine learning models and artificial intelligence (AI). In addition to promising faster and more efficient toxicity testing, NAMs have the potential to fundamentally transform today's regulatory work by allowing more human-relevant decision-making in terms of both hazard and exposure assessment. Yet, several obstacles hamper a broader application of NAMs in current regulatory risk assessment. Constraints in addressing repeated-dose toxicity, with particular reference to the chronic toxicity, and hesitance from relevant stakeholders, are major challenges for the implementation of NAMs in a broader context. Moreover, issues regarding predictivity, reproducibility and quantification need to be addressed and regulatory and legislative frameworks need to be adapted to NAMs. The conceptual perspective presented here 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. It 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).
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Schmeisser, S., Miccoli, A., Bergen�, M. V., Berggren, E., Braeuning, A., Busch, W., Desaintes, C., Gourmelon, A., Grafström, R., Harrill, J., Härtung, T., Herzler, M., Kass, G. E., Kleinstreuer, N., Leist, M., Luijten, M., Marx‐Stoelting, P., Poetz, O., Ravenzwaay, B. V., … Tralau, T. (2023). New approach methodologies in human regulatory toxicology – Not if, but how and when! Environment International, 178, 108082. https://doi.org/10.1016/j.envint.2023.108082
Schmeisser, Sebastian, et al. "New approach methodologies in human regulatory toxicology – Not if, but how and when!" Environment International, vol. 178, 2023, pp. 108082, https://doi.org/10.1016/j.envint.2023.108082.
Schmeisser, Sebastian, Andrea Miccoli, Martin von Bergen�, Elisabet Berggren, Albert Braeuning, Wibke Busch, Christian Desaintes, et al. "New approach methodologies in human regulatory toxicology – Not if, but how and when!" Environment International 178 (2023): 108082. https://doi.org/10.1016/j.envint.2023.108082.
Schmeisser S., Miccoli A., Bergen� M. V. [и др.] New approach methodologies in human regulatory toxicology – Not if, but how and when! // Environment International. — 2023. — Vol. 178. — P. 108082. — URL: https://doi.org/10.1016/j.envint.2023.108082
@article{schmeisser2023approach,
title = {{New approach methodologies in human regulatory toxicology – Not if, but how and when!}},
author = {Sebastian Schmeisser and Andrea Miccoli and Martin von Bergen� and Elisabet Berggren and Albert Braeuning and Wibke Busch and Christian Desaintes and Anne Gourmelon and Roland Grafström and Joshua Harrill and Thomas Härtung and Matthias Herzler and George E.N. Kass and Nicole Kleinstreuer and Marcel Leist and Mirjam Luijten and Philip Marx‐Stoelting and Oliver Poetz and Bennard van Ravenzwaay and Rob Roggeband and Vera Rogiers and Adrian B. Roth and Pascal Sandérs and Russell S. Thomas and Anne Marie Vinggaard and Mathieu Vinken and Bob van de Water and Andreas Luch and Tewes Tralau},
journal = {Environment International},
year = {2023},
volume = {178},
pages = {108082},
doi = {10.1016/j.envint.2023.108082},
url = {https://doi.org/10.1016/j.envint.2023.108082}
}TY - JOUR AU - Schmeisser, Sebastian AU - Miccoli, Andrea AU - Bergen�, Martin von AU - Berggren, Elisabet AU - Braeuning, Albert AU - Busch, Wibke AU - Desaintes, Christian AU - Gourmelon, Anne AU - Grafström, Roland AU - Harrill, Joshua AU - Härtung, Thomas AU - Herzler, Matthias AU - Kass, George E.N. AU - Kleinstreuer, Nicole AU - Leist, Marcel AU - Luijten, Mirjam AU - Marx‐Stoelting, Philip AU - Poetz, Oliver AU - Ravenzwaay, Bennard van AU - Roggeband, Rob AU - Rogiers, Vera AU - Roth, Adrian B. AU - Sandérs, Pascal AU - Thomas, Russell S. AU - Vinggaard, Anne Marie AU - Vinken, Mathieu AU - Water, Bob van de AU - Luch, Andreas AU - Tralau, Tewes TI - New approach methodologies in human regulatory toxicology – Not if, but how and when! JO - Environment International VL - 178 SP - 108082 PY - 2023 DA - 2023/07/04 DO - 10.1016/j.envint.2023.108082 UR - https://doi.org/10.1016/j.envint.2023.108082 ER -
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