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 …

Toxicity testing in the 21st century: progress in the past decade and future perspectives

D Krewski, ME Andersen, MG Tyshenko… - Archives of …, 2020 - Springer
Advances in the biological sciences have led to an ongoing paradigm shift in toxicity testing
based on expanded application of high-throughput in vitro screening and in silico methods …

Limitations of animal studies for predicting toxicity in clinical trials: is it time to rethink our current approach?

GA Van Norman - JACC: Basic to Translational Science, 2019 - jacc.org
Animal testing is used in pharmaceutical and industrial research to predict human toxicity,
and yet analysis suggests that animal models are poor predictors of drug safety in humans …

Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009

… Chemical Agency (ECHA) and European Food … - EFSA …, 2018 - Wiley Online Library
This Guidance describes how to perform hazard identification for endocrine‐disrupting
properties by following the scientific criteria which are outlined in Commission Delegated …

Advancing computational toxicology in the big data era by artificial intelligence: data-driven and mechanism-driven modeling for chemical toxicity

HL Ciallella, H Zhu - Chemical research in toxicology, 2019 - ACS Publications
In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act became the first
US legislation to advance chemical safety evaluations by utilizing novel testing approaches …

Utility of In Vitro Bioactivity as a Lower Bound Estimate of In Vivo Adverse Effect Levels and in Risk-Based Prioritization

K Paul Friedman, M Gagne, LH Loo… - Toxicological …, 2020 - academic.oup.com
Use of high-throughput, in vitro bioactivity data in setting a point-of-departure (POD) has the
potential to accelerate the pace of human health safety evaluation by informing screening …

Evaluating Chemicals for Thyroid Disruption: Opportunities and Challenges with in Vitro Testing and Adverse Outcome Pathway Approaches

PD Noyes, KP Friedman, P Browne… - Environmental …, 2019 - ehp.niehs.nih.gov
Background: Extensive clinical and experimental research documents the potential for
chemical disruption of thyroid hormone (TH) signaling through multiple molecular targets …

Development of a bioanalytical test battery for water quality monitoring: Fingerprinting identified micropollutants and their contribution to effects in surface water

PA Neale, R Altenburger, S Aït-Aïssa, F Brion, W Busch… - Water research, 2017 - Elsevier
Surface waters can contain a diverse range of organic pollutants, including pesticides,
pharmaceuticals and industrial compounds. While bioassays have been used for water …

The US Federal Tox21 Program: A strategic and operational plan for continued leadership

RS Thomas, RS Paules, A Simeonov, SC Fitzpatrick… - Altex, 2018 - pmc.ncbi.nlm.nih.gov
Background The traditional approaches to toxicity testing have posed multiple challenges for
evaluating the safety of industrial and environmental chemicals, pesticides, food additives …

Integrated Model of Chemical Perturbations of a Biological Pathway Using 18 In Vitro High-Throughput Screening Assays for the Estrogen Receptor

RS Judson, FM Magpantay, V Chickarmane… - Toxicological …, 2015 - academic.oup.com
We demonstrate a computational network model that integrates 18 in vitro, high-throughput
screening assays measuring estrogen receptor (ER) binding, dimerization, chromatin …