[HTML][HTML] Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology

C Rovida, T Barton-Maclaren, E Benfenati, F Caloni… - Altex, 2020 - ncbi.nlm.nih.gov
… RAx application for regulatory purposes in … read-across (ECHA RAAF), facing the issue
of regulatory acceptance from the point of view of the registrants of NAM-supported read-across

[PDF][PDF] Internationalizationof Read-Across as a Validated New Approach Method (NAM) for Regulatory Toxicology http://researchonline. ljmu. ac. uk/id/eprint/12865

C Rovida, T Barton-Maclaren, E Benfenati, MTD Cronin… - pdfs.semanticscholar.org
… assessment by using data from alternative methods. The CS were run under 2 conditions:
read-across without additional new approach data; addition of NAM data (primarily from …

Read-across approaches: current applications and regulatory acceptance in Korea, Japan, and China

BM Lee, SH Lee, T Yamada, S Park… - Journal of Toxicology …, 2022 - Taylor & Francis
… the widespread application of read-across are (1) insufficient documentation of validation,
(2… and variability in read-across when integrated with new approach methodologies. There is a …

Read-Across Methodology in Toxicological Risk Assessment

SE Escher, A Bitsch - Regulatory Toxicology, 2021 - Springer
New approach methodologies, such as in vitro assays and in silico models, have great
potential to strengthen read-across … (also for regulatory purposes), and integration of NAM data …

Setting the stage for next-generation risk assessment with non-animal approaches: the EU-ToxRisk project experience

MJ Moné, G Pallocca, SE Escher, T Exner… - Archives of …, 2020 - Springer
… strategy for read-across (RAx) as an animal-free approach in chemical … on the regulatory
implementation of new approaches. … and pre-validation of the EU-ToxRisk NAM toolbox is a step …

[HTML][HTML] Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?

J Sündermann, A Bitsch, R Kellner, T Doll - Regulatory Toxicology and …, 2024 - Elsevier
… and read-across for chemicals. Although read-across is not explicitly prohibited in the process
… Nonetheless, a scientifically justified read-across of material-based endpoints, as well as …

Developing and validating read-across workflows that enable decision making for toxicity and potency: Case studies with N-nitrosamines

S Kane, D Newman, DJ Ponting, E Rosser… - Computational …, 2024 - Elsevier
… The approach taken demonstrates how software implementing … read-across can support
decisions and how validation of the methods can increase confidence in the overall approach. …

A framework for chemical safety assessment incorporating new approach methodologies within REACH

N Ball, R Bars, PA Botham, A Cuciureanu… - Archives of …, 2022 - Springer
… in a new framework to provide validation of NAMs, in assessments such as read across, as
… We chose the current REACH regulatory guidelines to be the setting for our investigation, …

[HTML][HTML] A strategy to define applicability domains for read-across

C Pestana, SJ Enoch, JW Firman, JC Madden… - Computational …, 2022 - Elsevier
… a regulatory context, but as yet no formalised process exists … from which a reliable read-across
prediction can be made. … and / or in vitro New Approach Methodology (NAM) data may …

… and coverage of selected in silico (liver) metabolism tools relative to reported studies in the literature to inform analogue selection in read-across: A case study

M Boyce, B Meyer, C Grulke, L Lizarraga… - Computational …, 2022 - Elsevier
… Changes in the regulatory landscape of chemical safety assessment call for the use of New
Approach Methodologies (NAMs) including read-across to fill data gaps. One critical aspect …