New Approach Methodologies in Regulatory Toxicology: Volume II

Building on the success of Volume I, this Research Topic continues to explore the rapidly evolving landscape of New Approach Methodologies (NAMs) and their integration into regulatory toxicology frameworks. Since the launch of the first volume, the field has seen meaningful progress: increasing regulatory acceptance of NAM-derived data, expanded guidance from agencies such as the US EPA and ECHA, and a growing body of evidence supporting the predictive validity of in vitro and computational tools. At the same time, new challenges and opportunities have emerged — from the application of artificial intelligence and machine learning to the development of advanced microphysiological systems — making continued scientific dialogue more important than ever.This second volume aims to capture these advances and push the conversation further, with a particular focus on regulatory implementation, emerging technologies, and real-world application across chemical classes and endpoints. The goal remains to bridge the gap between innovative methodologies and their practical use in regulatory and product stewardship decisions, while promoting the 3Rs (Replacement, Reduction, and Refinement) in toxicology testing.We welcome original research, reviews, case studies, and perspectives addressing, but not limited to, the following themes:- Advances in AI and machine learning for predictive toxicology and hazard identification;- AI-assisted data mining, synthesis, and extrapolation in regulatory NAM workflows: opportunities, case studies, and guardrails;- Organ-on-a-chip and microphysiological systems as regulatory tools;- Progress in regulatory acceptance and submission of NAM-based data packages;- Multi-omics approaches (transcriptomics, metabolomics, proteomics) in safety assessment- NAMs for specific endpoints: developmental and reproductive toxicology, endocrine disruption, and neurotoxicity; - Integrated Approaches to Testing and Assessment (IATA) and defined approaches (DAs);- Cross-species extrapolation and interspecies variability using NAMs;- Environmental NAMs: application to ecological risk assessment and mixture toxicity;- Global harmonisation of NAM-based regulatory frameworks;- Uncertainty characterisation and weight-of-evidence approaches in NAM integration;- Continued case studies in IVIVE, HTTK, and complex substance assessment (UVCBs, multi-constituent substances) Topic editors: Satinder S Sarang, Andreas Karwath Source: https://www.frontiersin.org/research-topics/81982/new-approach-methodologies-in-regulatory-toxicology-volume-ii