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Monthly Archive for: "November, 2017"
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Data Available for Project on Predictive Models for Acute Oral Toxicity

NICEATM invites participation in a global project to develop in silico models of acute oral systemic toxicity that predict five specific endpoints needed by regulatory agencies. Data to train models for this project are now available on the NICEATM website. ICCVAM agencies identified multiple endpoints of interest for this project, including identification of “very toxic” […]
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NIEHS Webinar Series on Adverse Outcome Pathways Continues November 29

The Superfund Research Program of the National Institute of Environmental Health Sciences (NIEHS) is presenting a webinar series on adverse outcome pathways (AOPs), structured ways to represent biological events leading to adverse health effects. The second webinar in the series will be presented November 29. Presenters will discuss the development of AOPs and how they […]
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FDA Requests Comments on Draft Guidance for Reproductive Toxicity Testing

The U.S. Food and Drug Administration (FDA) has requested comment on draft guidance ICH S5(R3), “Detection of Toxicity to Reproduction for Human Pharmaceuticals.” This document clarifies the qualification and potential use of alternative assays to assess reproductive risk and includes a list of compounds suggested for qualification of assays. FDA recognizes that this list is […]
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ICATM Position Paper on Skin Sensitization Available

A position paper by representatives of the International Cooperation on Alternative Test Methods (ICATM) proposes practical ways to further promote the regulatory use and facilitate adoption of non-animal defined approaches for skin sensitization assessments. The paper, published online November 10 by Archives of Toxicology, is a work product of the October 2016 workshop, International Regulatory […]
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National Academy of Sciences Workshop On “Understanding Pathways to a Paradigm Shift in Toxicity Testing and Decision Making” Begins November 20

Discuss the key factors that influence how new science is incorporated into the environmental health decision making process at a free National Academies of Sciences, Engineering, and Medicine workshop on November 20-21 in Washington, DC and via webcast. New approaches for understanding the toxicity of chemicals in humans—from high-throughput cell-based in vitro studies to tissue […]
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ICCVAM Initiates Project on Predictive Models for Acute Oral Toxicity

The ICCVAM Acute Toxicity Workgroup is initiating a global project to develop in silico models of acute oral systemic toxicity that predict specific endpoints needed by regulatory agencies. These endpoints include identification of “very toxic” chemicals (LD50 less than 50 mg/kg) and “nontoxic” chemicals (LD50 greater than or equal to 2000 mg/kg), point estimates for […]
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NIH Awards $2.34 Million to GBSI for Training to Improve Research Reproducibility

WASHINGTON, D.C., November 13, 2017 – The National Institutes of Health (NIH) has awarded the Global Biological Standards Institute (GBSI) $2.34 million over five years for a groundbreaking experimental design training project to improve reproducibility in preclinical research. The project, entitled “Producing Reproducible Experiments by Promoting Reverse Experimental Design” (PREPaRED),* is a collaborative educational partnership […]
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Improving Species Extrapolation for Protecting Endangered Species

Planning to be in Minneapolis next week for the Society of Environmental Toxicology and Chemistry (SETAC) North America Annual Meeting? Please join us for “Improving Species Extrapolation for Protecting Endangered Species: What Is Available and What Is Needed?” Currently, data used to protect endangered species has the unintended consequence of helping to increase animal testing […]
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FDA Releases Draft Guidances on In Vitro Metabolism and Drug Interactions Studies

The FDA recently issued two draft guidances for public comment: In Vitro Metabolism and Transporter-Mediated Drug-Drug Interaction Studies Clinical Drug Interactions Studies – Study Design, Data, Analysis, and Clinical Implications Together, the two draft guidances provide a systemic, risk-based approach to help drug developers evaluate investigational new drugs for potential drug-drug interactions (DDIs) during drug […]
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