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The application of existing genotoxicity methodologies for grou** of nanomaterials: towards an integrated approach to testing and assessment
The incorporation of nanomaterials (NMs) in consumer products has proven to be highly valuable in many sectors. Unfortunately, however, the same nano...
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A framework for chemical safety assessment incorporating new approach methodologies within REACH
The long-term investment in new approach methodologies (NAMs) within the EU and other parts of the world is beginning to result in an emerging...
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Standard set of network outcomes for traumatic spinal cord injury: a consensus-based approach using the Delphi method
Study designConsensus study.
ObjectivesThe purpose of this study is to define a standardized (network) outcomes set for traumatic spinal cord injury...
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The use of Bayesian methodology in the development and validation of a tiered assessment approach towards prediction of rat acute oral toxicity
There exists consensus that the traditional means by which safety of chemicals is assessed—namely through reliance upon apical outcomes obtained...
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Network approach in liquidomics landscape
Tissue-based biopsy is the present main tool to explore the molecular landscape of cancer, but it also has many limits to be frequently executed,...
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A Strength-Based Approach to Cancer Prevention in Latinxs
As Latinxs become exposed to US culture, their risk for many chronic diseases increases, including the risk of cancer. On average, less acculturated...
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Risk Assessment of Food Additives
Food additives are substances used for technological purposes, such as preservation, sweetening, or coloring, during the production of food. The...
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Grou** of orally ingested silica nanomaterials via use of an integrated approach to testing and assessment to streamline risk assessment
BackgroundNanomaterials can exist in different nanoforms (NFs). Their grou** may be supported by the formulation of hypotheses which can be...
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Risk Assessment of Food Additives
Food additives are substances used for technological purposes, such as preservation, sweetening, or coloring, during the production of food. The...
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Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum
Pre-existing adeno-associated viruses (AAV) neutralizing antibodies (NAb) can prevent AAV vectors from transducing target tissues. The immune...
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Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method
Immunogenicity evaluation is a critical part of drug development. Regulatory guidelines from multiple health agencies provide recommendations for the...
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Applying genomics in regulatory toxicology: a report of the ECETOC workshop on omics threshold on non-adversity
In a joint effort involving scientists from academia, industry and regulatory agencies, ECETOC’s activities in Omics have led to conceptual proposals...
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Multistain deep learning for prediction of prognosis and therapy response in colorectal cancer
Although it has long been known that the immune cell composition has a strong prognostic and predictive value in colorectal cancer (CRC), scoring...
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Environmental Risk Assessment Framework for Dredging Sounds
Underwater sounds produced from anthropogenic sources may pose risks to aquatic life, yet there is much uncertainty regarding the prediction of these...
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Integrated approach to functional analysis of an ERBB2 variant of unknown significance detected by a cancer gene panel test
PurposeDealing with variants of unknown significance (VUS) is an important issue in the clinical application of NGS-based cancer gene panel tests. We...
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Tumour budding-based grading as independent prognostic biomarker in HPV-positive and HPV-negative head and neck cancer
BackgroundThe prognostic significance of tumour budding (TB) and minimal cell nest size (MCNS) was shown in human papillomavirus (HPV)-negative head...
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Deep learning for fully-automated nuclear pleomorphism scoring in breast cancer
To guide the choice of treatment, every new breast cancer is assessed for aggressiveness (i.e., graded) by an experienced histopathologist....
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Investigating the in vitro steatotic mixture effects of similarly and dissimilarly acting test compounds using an adverse outcome pathway-based approach
Within the EuroMix project, we have previously developed an adverse outcome pathway (AOP)-based in vitro assay toolbox to investigate the combined...
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Benchmark Dose Approach in Regulatory Toxicology
The Benchmark-Dose (BMD) approach aims at determining an exposure level/dose corresponding to a predefined change in response, the Benchmark...
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Benchmark Dose Approach in Regulatory Toxicology
The Benchmark-Dose (BMD) approach aims at determining an exposure level/dose corresponding to a predefined change in response, the Benchmark Response...