[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 …

The relationship between typical environmental endocrine disruptors and kidney disease

X Zhang, JA Flaws, MJ Spinella, J Irudayaraj - Toxics, 2022 - mdpi.com
Endocrine disrupting chemicals (EDCs) are exogenous substances that alter the endocrine
function of an organism, to result in adverse effects on growth and development …

[HTML][HTML] Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients

MP Dent, E Vaillancourt, RS Thomas… - Regulatory Toxicology …, 2021 - Elsevier
Next generation risk assessment (NGRA) is an exposure-led, hypothesis-driven approach
that has the potential to support animal-free safety decision-making. However, significant …

Progress in toxicogenomics to protect human health

MJ Meier, J Harrill, K Johnson, RS Thomas… - Nature Reviews …, 2024 - nature.com
Toxicogenomics measures molecular features, such as transcripts, proteins, metabolites and
epigenomic modifications, to understand and predict the toxicological effects of …

A transformative vision for an omics-based regulatory chemical testing paradigm

KJ Johnson, SS Auerbach, T Stevens… - Toxicological …, 2022 - academic.oup.com
Use of molecular data in human and ecological health risk assessments of industrial
chemicals and agrochemicals has been anticipated by the scientific community for many …

Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology

JA Harrill, MR Viant, CL Yauk, M Sachana… - Regulatory Toxicology …, 2021 - Elsevier
Omics methodologies are widely used in toxicological research to understand modes and
mechanisms of toxicity. Increasingly, these methodologies are being applied to questions of …

Assessing chemical carcinogenicity: hazard identification, classification, and risk assessment. Insight from a toxicology forum state-of-the-science workshop

SP Felter, VS Bhat, PA Botham… - Critical Reviews in …, 2021 - Taylor & Francis
Abstract The Toxicology Forum convened an international state-of-the-science workshop
Assessing Chemical Carcinogenicity: Hazard Identification, Classification, and Risk …

A modern genotoxicity testing paradigm: Integration of the high-throughput CometChip® and the TGx-DDI transcriptomic biomarker in human HepaRG™ cell cultures

JK Buick, A Williams, MJ Meier, CD Swartz… - Frontiers in Public …, 2021 - frontiersin.org
Higher-throughput, mode-of-action-based assays provide a valuable approach to expedite
chemical evaluation for human health risk assessment. In this study, we combined the high …

Characterizing variability and uncertainty associated with transcriptomic dose–response modeling

JD Ewald, N Basu, D Crump… - … Science & Technology, 2022 - ACS Publications
Transcriptomics dose–response analysis (TDRA) has emerged as a promising approach for
integrating toxicogenomics data into a risk assessment context; however, variability and …

Reproducibility of organ-level effects in repeat dose animal studies

KP Friedman, MJ Foster, LL Pham, M Feshuk… - Computational …, 2023 - Elsevier
This work estimates benchmarks for new approach method (NAM) performance in predicting
organ-level effects in repeat dose studies of adult animals based on variability in replicate …