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Application of New Statistical Distribution Approaches for Environmental Mixture Risk Assessment: A Case Study

Science of the Total Environment, 2019

Aude Kienzler, Stephanie Bopp, Marlies Halder, Michelle Embry, Andrew Worth

There is growing evidence that single substances present below their individual thresholds of effect may still contribute to combined effects. Here, the possible use of ecotoxicological threshold concentrations of no concern (i.e. 5th percentile of statistical distribution of ecotoxicological values) is investigated to fill data gaps in MRA.

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TGx-DDI, A Transcriptomic Biomarker for Genotoxicity Hazard Assessment of Pharmaceuticals and Environmental Chemicals

Frontiers in Big Data, 2019

Heng-Hong Li, Carole Yauk, Renxiang Chen, Danial R. Hyduke, Andrew Williams, Roland Frötschl, Heidrun C. Ellinger-Ziegelbauer, Syril Pettit, Jiri Aubrecht, and Albert J. Fornace Jr.

Genotoxicity testing is an essential component of the safety assessment paradigm required by regulatory agencies world-wide for analysis of drug candidates, and environmental and industrial chemicals. Current genotoxicity testing batteries feature a high incidence of irrelevant positive findings – particularly for in vitro chromosomal damage (CD) assays. Thus, regulators are urgently in need of new testing approaches to meet legislated mandates. Using machine learning, we identified a set of transcripts that responds predictably to DNA-damage in human cells that we refer to as the TGx-DDI biomarker, which was originally referred to as TGx-28.65.

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Stakeholder Perspectives on Addressing Adverse Events from Adjuvant Cancer Therapy: A Qualitative Study

Cancer, 2019

Syril D. Pettit, Pamela Silberman, Kristen Hassmiller Lich, Rebecca A. Kirch, Steven E. Lipshultz, Randall Teal, Ethan Basch

With increasing survival rates, a growing population of patients with cancer have received or will receive adjuvant therapy to prevent cancer recurrences. Patients and caregivers will confront the complexities of balancing the preventative benefits of adjuvant therapy with possible near‐term or long‐term adverse events (AEs). However, to the authors’ knowledge, limited information is available regarding how stakeholders use or desire to use adjuvant‐related AE information to inform the care of patients with cancer.

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Mode of Action (MOA) Classifications in the EnviroTox Database: Development and Implementation of a Consensus MOA Classification

Environmental Toxicology and Chemistry, 2019

Aude Kienzler, Kristin A. Connors, Mark Bonnell, Mace G. Barron, Amy Beasley, Cristina G. Inglis, Teresa J. Norberg‐King, Todd Martin, Hans Sanderson, Nathalie Vallotton, Peter Wilson, Michelle R. Embry

Multiple modes of action (MOA) frameworks have been developed in aquatic ecotoxicology, mainly based on fish toxicity. These frameworks provide information on a key determinant of chemical toxicity, but the MOA categories and level of specificity remain unique to each of the classification schemes. This study aimed to develop a consensus MOA assignment within EnviroTox (https://envirotoxdatabase.org/), a curated in vivo aquatic toxicity database, based on the following MOA classification schemes: Verhaar (modified) framework, ASTER, TEST, and OASIS.

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