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 …

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

AO Stucki, TS Barton-Maclaren, Y Bhuller… - Frontiers in …, 2022 - frontiersin.org
New approach methodologies (NAMs) are increasingly being used for regulatory decision
making by agencies worldwide because of their potential to reliably and efficiently produce …

[HTML][HTML] Implementing New Approach Methodologies (NAMs) in food safety assessments: Strategic objectives and actions taken by the European Food Safety …

I Cattaneo, MC Astuto, M Binaglia, Y Devos… - Trends in Food Science …, 2023 - Elsevier
Abstract Background New Approach Methodologies (NAMs) comprise in silico and in vitro
methods applied as alternative to animal testing. Even though NAMs are already fully …

[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] The application of organ-on-chip models for the prediction of human pharmacokinetic profiles during drug development

M Keuper-Navis, M Walles, B Poller… - Pharmacological …, 2023 - Elsevier
Abstract Organ-on-chip (OoC) technology has led to in vitro models with many new
possibilities compared to conventional in vitro and in vivo models. In this review, the …

A call for a Human Exposome Project

T Hartung - ALTEX-Alternatives to animal experimentation, 2023 - altex.org
Four decades of the Human Genome Project and its consequences have shown how the
entrepreneurial state, through significant investment into science, can drive scientific …

OECD harmonised template 201: Structuring and reporting mechanistic information to foster the integration of new approach methodologies for hazard and risk …

E Carnesecchi, I Langezaal, P Browne… - Regulatory Toxicology …, 2023 - Elsevier
Abstract In the European Union, the Chemicals Strategy for Sustainability (CSS) highlights
the need to enhance the identification and assessment of substances of concern while …

Big question to developing solutions: A decade of progress in the development of aquatic new approach methodologies from 2012 to 2022

LM Langan, M Paparella, N Burden… - Environmental …, 2024 - Wiley Online Library
In 2012, 20 key questions related to hazard and exposure assessment and environmental
and health risks of pharmaceuticals and personal care products in the natural environment …

Integration of omics approaches enhances the impact of scientific research in environmental applications

A Gruszecka-Kosowska, A Ampatzoglou… - International Journal of …, 2022 - mdpi.com
Research in the field of environmental sciences currently attracts a lot of attention. As the
pollution of the environment is already pushing the earth beyond its homeostasis state …

Roadmap for action on Risk Assessment of Combined Exposure to Multiple Chemicals (RACEMiC)

E de Jong, H van der Voet… - EFSA Supporting …, 2022 - Wiley Online Library
EFSA's aim by 2030, is that the Agency and its partners will be equipped for the routine
implementation of human health risk assessment to multiple chemicals, across EFSA's …