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Monthly Archive for: "February, 2020"
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Kleinstreuer Assumes Leadership of NICEATM

As of January 1, Nicole Kleinstreuer has assumed the role of Acting NICEATM Director. Kleinstreuer has been NICEATM Deputy Director since 2016. Before that she worked for ILS, the NICEATM support contractor. In both roles, she has contributed significantly to the development of NICEATM’s capabilities in computational toxicology. Kleinstreuer received her Ph.D. in bioengineering from […]
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Paper Describes Framework for Evaluation of NAMs

Former NICEATM Director Warren Casey and NICEATM Acting Director Nicole Kleinstreuer are co-authors on a paper that describes a framework for evaluating new approach methodologies (NAMs). The goal of this framework, developed by a multi-stakeholder group of industry, academic, and regulatory experts, is to provide a structure to collect relevant information to build confidence that […]
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New FDA Guidance Available for In Vitro Drug Interaction Studies

The U.S. Food and Drug Administration (FDA) published “In Vitro Drug Interaction Studies – Cytochrome P450 Enzyme- and Transporter-mediated Drug Interactions Guidance for Industry” in January. This guidance is intended to help drug developers plan and evaluate studies to determine the drug-drug interaction (DDI) potential of an investigational drug product. It focuses on in vitro […]
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Paper Describes Predictive Model for Androgenic Activity

A paper now available online from Environmental Health Perspectives describes a worldwide consortium led by the U.S. Environmental Protection Agency (EPA) to develop models to virtually screen chemicals for their potential androgenic activity. The paper was coauthored by Acting NICEATM Director Nicole Kleinstreuer; the first author is Kamel Mansouri, ILS (contractor supporting NICEATM). Predictions generated […]
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Presentations Available from EPA Conference on NAMs

Presentation slides are available from the First Annual Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing, presented by the U.S. Environmental Protection Agency (EPA) on December 17. This conference was one of EPA’s commitments in the “Directive to Prioritize Efforts to Reduce Animal […]
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