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

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

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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Assessing drug-induced long QT and proarrhythmic risk using human stem cell-derived cardiomyocytes in a Ca2+ imaging assay: Evaluation of 28 CiPA compounds at three test sites

A consortium, multi-site approach to testing in vitro assay technology for prediction of drug-induced TdP. The authors sought to test calcium transient assays using the CiPA 28 drugs.

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Improving Attribution of Adverse Events in Oncology Clinical Trials

Attribution of adverse events (AEs) is critical to oncology drug development and the regulatory process. However, processes for determining the causality of AEs are often sub-optimal, unreliable, and inefficient. Thus, a toxicity-attribution workshop was conducted in Silver Spring, MD to develop guidance for improving attribution of AEs in oncology clinical trials.

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