[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 …

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 …

Adverse outcome pathways: opportunities, limitations and open questions

M Leist, A Ghallab, R Graepel, R Marchan… - Archives of …, 2017 - Springer
Adverse outcome pathways (AOPs) are a recent toxicological construct that connects, in a
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 …

[HTML][HTML] A human brain microphysiological system derived from induced pluripotent stem cells to study neurological diseases and toxicity

D Pamies, P Barrera, K Block, G Makri, A Kumar… - Altex, 2017 - ncbi.nlm.nih.gov
Human in vitro models of brain neurophysiology are needed to investigate molecular and
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 …

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) …

[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 …

[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 …

Brain-on-a-chip model enables analysis of human neuronal differentiation and chemotaxis

O Kilic, D Pamies, E Lavell, P Schiapparelli, Y Feng… - Lab on a Chip, 2016 - pubs.rsc.org
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 …