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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 …
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 …
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 …
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 …
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
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 …
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
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 …
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
Background: Extensive clinical and experimental research documents the potential for
chemical disruption of thyroid hormone (TH) signaling through multiple molecular targets …
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
Surface waters can contain a diverse range of organic pollutants, including pesticides,
pharmaceuticals and industrial compounds. While bioassays have been used for water …
pharmaceuticals and industrial compounds. While bioassays have been used for water …
The US Federal Tox21 Program: A strategic and operational plan for continued leadership
Background The traditional approaches to toxicity testing have posed multiple challenges for
evaluating the safety of industrial and environmental chemicals, pesticides, food additives …
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
We demonstrate a computational network model that integrates 18 in vitro, high-throughput
screening assays measuring estrogen receptor (ER) binding, dimerization, chromatin …
screening assays measuring estrogen receptor (ER) binding, dimerization, chromatin …