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Developing Toxicity and Pharmacokinetic Models for an in vitro Integrated Organ Platform (HuDMOP™)

In vitro methods capable of describing systemic effects of chemicals require use of multiple tissue types connected with a common perfusate. This arrangement allows integration of absorption, metabolism and toxicity data over extended times in vitro and provides a novel, animal-free tool for chemical, cosmetic, and pharmaceutical testing. In order to test this, a study on the uptake and distribution of acetaminophen (APAP) in a human dynamic multi-organ plate (HuDMOP™) with three tissue surrogates arranged in series: first…Read more »

An Open Source in silico Prediction Model of Hepatic Intrinsic Clearance for in vitro to in vivo Extrapolation

Chemical risk assessment is moving away from animal testing replacing it with computational and in vitro approaches in risk assessment. Dosimetry, by determining the amounts and key rates for distribution of a chemical in the body, is essential for the use of new approach methodologies in risk-based decision making. Use of models such as high-throughput in vitro to in vivo extrapolation (HT-IVIVE) has…Read more »

Development of additional workflows for risk assessment and prioritization for the PLETHEM R Package

Over the past three years we have been developing the population life-course exposure to health effects model (PLETHEM) – the open source R package that is designed to provide tools that can be used to bridge the source-to-outcome continuum. Pharmacokinetic modeling is becoming increasingly important in chemical safety decision making, with applications in prioritizing risk assessment by establishing margins of exposure for chemicals and extrapolating hazard across different ages, population cohorts, or occupational classes. As a part of our effort to provide the community with…Read more »

Hepatotoxic Response in 2D and 3D Co-culture Models Differs From Hepatocyte-alone Models

Safety assessment strategies that rely on testing species-relevant cells in vitro are advancing, yet there are currently no in vitro alternatives for hepatotoxicity testing accepted by regulators. An organotypic rat model, capable of predicting rat in vivo responses to hepatotoxicants, will provide an affordable and ethical alternative to in vivo rat models currently utilized. An ideal in vitro liver model for hepatotoxicity testing would include hepatocytes and the non-parenchymal cells (NPCs) (i.e., hepatic stellate cells, Kupffer cells, and liver sinusoidal endothelial cells), and would support…Read more »

Integration of Transcriptomic Point of Departure Metrics Into the MoAviz Visualization Framework

Gene expression profiling is emerging as a viable way to evaluate mode of action and points of departure and has the potential to drastically reduce testing costs and product development time. The first steps of using transcriptional responses as a basis of safety assessment are being taken. However, several important considerations remain unresolved, including how to translate expression changes into adverse outcome pathways or other definitions of mode of action…Read more »

ScitoVation Announces Release of PLETHEM

Software to Integrate Chemical Exposures and Health Effects Durham, N.C., March 25, 2019—ScitoVation, a solution leader recognized as an industry expert in cell-based assays and computational methods, today announced the… Read more »