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National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterJanuary 2021

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)

By Catherine Sprankle

ALTBIB moves to NTP website

The National Library of Medicine (NLM) ALTBIB literature search tool has moved to the NTP website. It will be maintained by NICEATM and can be accessed from the main NICEATM page.

ALTBIB is the Bibliography on Alternatives to the Use of Live Vertebrates in Biomedical Research and Testing. NLM developed ALTBIB to provide access to PubMed citations for users seeking information on alternatives to animal testing. Many citations provide access to free full text.

The search strategy on the new ALTBIB site has been updated to capture key topics of current interest such as microphysiological systems and quantitative structure activity relationship models. The content has been reorganized to provide additional user support, and more links have been added to the “Additional Resources” list. Users can still edit the ALTBIB search strategy to broaden or narrow searches. The list of keywords related to specific topics that was available on the NLM ALTBIB site is not yet available on the new NICEATM site. This list is being updated and revised and will be added to the NICEATM site in early 2021.

A link on the NLM site will temporarily redirect users looking for ALTBIB on the NLM site to its new home at NICEATM. However, ALTBIB users should update any bookmarks to reflect the new location.

ICCVAM Communities of Practice webinar on mixtures toxicity January 26

Registration is open for a webinar, “Non-animal Approaches for Mixtures Assessment,” scheduled for Tuesday, January 26, at 9:00 a.m. EST. This is the annual Communities of Practice webinar presented by NICEATM on behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).

While most available toxicity data are for single chemicals, humans are often exposed to chemicals as mixtures. Assessing the safety of a mixture is a complex process that requires consideration of both the toxicity of each chemical component of the mixture and the potential for interaction among the components to affect toxicity of the overall mixture. Additionally, most alternative methods and approaches used for assessing chemical safety are developed and evaluated using single chemicals. This can result in lack of clarity about whether a method is appropriate to use for assessing toxicity of a particular mixture.

This webinar will discuss new approach methodologies for assessing exposure to, and potential hazards associated with, chemical mixtures. Key insights and ongoing activities will be described in three presentations featuring speakers from U.S. federal research and regulatory agencies.

FDA launches pilot program to support novel approaches to drug development

On November 30, the U.S. Food and Drug Administration (FDA) announced establishment of the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. This program is designed to encourage innovation of drug development tools (DDTs) that are out of scope for existing DDT qualification programs but may still be useful for drug development. DDTs are methods, materials, or measures that have the potential to facilitate drug development.

Approaches that could be considered under ISTAND include using tissue chips (also known as microphysiological systems) to assess safety or efficacy questions; developing novel nonclinical pharmacology/toxicology assays; or using artificial intelligence-based algorithms to evaluate patients, develop novel endpoints, or inform study design. More information about the ISTAND program is available on the FDA website.

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The Update Newsletter is produced by NTP Office of Liaison, Policy, and Review. The text is not copyrighted and can be reprinted without permission. If you use parts of the Update Newsletter in your publication, we ask that you provide us with a copy for our records. We welcome your comments and suggestions.

Director of Office of Liaison, Policy, and Review and Editor-in-Chief: Mary Wolfe | Managing Editor: Anna Lee Mosley