[HTML][HTML] New approach methodologies in human regulatory toxicology–Not if, but how and when!
S Schmeisser, A Miccoli, M von Bergen… - Environment …, 2023 - Elsevier
The predominantly animal-centric approach of chemical safety assessment has increasingly
come under pressure. Society is questioning overall performance, sustainability, continued …
come under pressure. Society is questioning overall performance, sustainability, continued …
A framework for establishing scientific confidence in new approach methodologies
AJ Van Der Zalm, J Barroso, P Browne, W Casey… - Archives of …, 2022 - Springer
Robust and efficient processes are needed to establish scientific confidence in new
approach methodologies (NAMs) if they are to be considered for regulatory applications …
approach methodologies (NAMs) if they are to be considered for regulatory applications …
Adverse outcome pathways: opportunities, limitations and open questions
Adverse outcome pathways (AOPs) are a recent toxicological construct that connects, in a
formalized, transparent and quality-controlled way, mechanistic information to apical …
formalized, transparent and quality-controlled way, mechanistic information to apical …
Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach …
F Pistollato, F Madia, R Corvi, S Munn, E Grignard… - Archives of …, 2021 - Springer
Abstract The EU Directive 2010/63/EU on the protection of animals used for scientific
purposes and other EU regulations, such as REACH and the Cosmetic Products Regulation …
purposes and other EU regulations, such as REACH and the Cosmetic Products Regulation …
[HTML][HTML] A human brain microphysiological system derived from induced pluripotent stem cells to study neurological diseases and toxicity
Human in vitro models of brain neurophysiology are needed to investigate molecular and
cellular mechanisms associated with neurological disorders and neurotoxicity. We have …
cellular mechanisms associated with neurological disorders and neurotoxicity. We have …
[HTML][HTML] Recommendation on test readiness criteria for new approach methods (NAM) in toxicology: exemplified for developmental neurotoxicity (DNT)
A Bal-Price, HT Hogberg, KM Crofton, M Daneshian… - Altex, 2018 - ncbi.nlm.nih.gov
Multiple non-animal-based test methods have never been formally validated. In order to use
such new approach methods (NAMs) in a regulatory context, criteria to define their …
such new approach methods (NAMs) in a regulatory context, criteria to define their …
Gene–environment interactions in developmental neurotoxicity: a case study of synergy between chlorpyrifos and CHD8 knockout in human brainspheres
S Modafferi, X Zhong, A Kleensang… - Environmental …, 2021 - ehp.niehs.nih.gov
Background: Autism spectrum disorder (ASD) is a major public health concern caused by
complex genetic and environmental components. Mechanisms of gene–environment (G× E) …
complex genetic and environmental components. Mechanisms of gene–environment (G× E) …
[HTML][HTML] Establishment of a human cell-based in vitro battery to assess developmental neurotoxicity hazard of chemicals
J Blum, S Masjosthusmann, K Bartmann, F Bendt… - Chemosphere, 2023 - Elsevier
Developmental neurotoxicity (DNT) is a major safety concern for all chemicals of the human
exposome. However, DNT data from animal studies are available for only a small …
exposome. However, DNT data from animal studies are available for only a small …
[HTML][HTML] Strategies to improve the regulatory assessment of developmental neurotoxicity (DNT) using in vitro methods
A Bal-Price, F Pistollato, M Sachana, SK Bopp… - Toxicology and applied …, 2018 - Elsevier
Currently, the identification of chemicals that have the potential to induce developmental
neurotoxicity (DNT) is based on animal testing. Since at the regulatory level, systematic …
neurotoxicity (DNT) is based on animal testing. Since at the regulatory level, systematic …
Brain-on-a-chip model enables analysis of human neuronal differentiation and chemotaxis
Migration of neural progenitors in the complex tissue environment of the central nervous
system is not well understood. Progress in this area has the potential to drive breakthroughs …
system is not well understood. Progress in this area has the potential to drive breakthroughs …