Skip to main content
Consensus Study Report

VIEW LARGER COVER

The Transformational Medical Technologies (TMT) has been a unique component of the U.S. Department of Defense (DoD) medical biodefense efforts since 2006. Its mission is to advance countermeasure research and development in support of the broader goal of the DoD to protect warfighters from emerging infectious diseases and future genetically engineered biological weapons. The TMT, using advanced science and technology approaches, focused on the development of roadspectrum countermeasures that target common host and pathogen pathways or enhance the host's immune response. Many of these pathogens are lethal or cause such debilitating diseases in humans that it is ethically inappropriate to test the efficacy of these countermeasures in human volunteers. In lieu of human participants, these products may be tested in animals and approved for human use under the provisions of the Food and Drug Administration (FDA)'s 2002 Animal Rule. The reliance on animal models for the development and licensure of medical countermeasures against biothreats is challenging for a number of reasons.

The ad hoc Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents prepared a consensus report that would address the challenges stemming from developing and testing medical countermeasures against biothreat agents in animal models. Animal Models for Assessing Countermeasures to Bioterrorism Agents evaluates how well the existing TMT-employed or candidate animal models reflect the pathophysiology, clinical picture, and treatment of human disease as related to the agents of interest. The report addresses the process and/or feasibility of developing new animal models for critical biodefense research, placing emphasis on the need for a robust and expeditious validation process in terms of the FDA's Animal Rule. The report also evaluates alternatives to the use of animal models based on the premise of the Three Rs.

Suggested Citation

National Research Council. 2011. Animal Models for Assessing Countermeasures to Bioterrorism Agents. Washington, DC: The National Academies Press. https://doi.org/10.17226/13233.

Import this citation to:

Publication Info

152 pages |  8.5 x 11 | 

ISBNs: 
  • Paperback:  978-0-309-21909-9
  • Ebook:  978-0-309-21912-9
DOI: https://doi.org/10.17226/13233

Copyright Information

The National Academies Press (NAP) has partnered with Copyright Clearance Center's Marketplace service to offer you a variety of options for reusing NAP content. Through Marketplace, you may request permission to reprint NAP content in another publication, course pack, secure website, or other media. Marketplace allows you to instantly obtain permission, pay related fees, and print a license directly from the NAP website. The complete terms and conditions of your reuse license can be found in the license agreement that will be made available to you during the online order process. To request permission through Marketplace you are required to create an account by filling out a simple online form. The following list describes license reuses offered by the NAP through Marketplace:

  • Republish text, tables, figures, or images in print
  • Post on a secure Intranet/Extranet website
  • Use in a PowerPoint Presentation
  • Distribute via CD-ROM
  • Photocopy

Click here to obtain permission for the above reuses. If you have questions or comments concerning the Marketplace service, please contact:

Marketplace Support
International +1.978.646.2600
US Toll Free +1.855.239.3415
E-mail: support@copyright.com
marketplace.copyright.com

To request permission to distribute a PDF, please contact our Customer Service Department at customer_service@nap.edu.

loading iconLoading stats for Animal Models for Assessing Countermeasures to Bioterrorism Agents...