Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents's Books

Animal Models for Assessing Countermeasures to Bioterrorism Agents

By: National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents

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Animal Models for Assessing Countermeasures to Bioterrorism Agents

By: National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents

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.

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152

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National Academies Press

Published Date

ISBN 10

0309219094

ISBN 13

9780309219099

Animal Models for Assessing Countermeasures to Bioterrorism Agents

By: National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents

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Animal Models for Assessing Countermeasures to Bioterrorism Agents

By: National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents

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152

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National Academies Press

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ISBN 10

0309219094

ISBN 13

9780309219099

Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents

Appropriate Use of Animal Models

By: National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Board on Life Sciences,Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents

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Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents

Appropriate Use of Animal Models

The National Institute of Allergy and Infectious Diseases (NIAID) gives the highest priority to developing countermeasures against bioterrorism agents that are highly infective when dispersed in aerosol form. Developing drugs to prevent or treat illnesses caused by bioterrorism agents requires testing their effectiveness in animals since human clinical trials would be unethical. At the request of NIAID, the National Academies conducted a study to examine how such testing could be improved. Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents provides recommendations to researchers on selecting the kinds of animal models, aerosol generators, and bioterrorism agent doses that would produce conditions that most closely mimic the disease process in humans. It also urges researchers to fully document experimental parameters in the literature so that studies can be reproduced and compared. The book recommends that all unclassified data on bioterrorism agent studies-including unclassified, unpublished data from U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)-be published in the open literature. The book also calls on the U.S. Food and Drug Administration to improve the process by which bioterrorism countermeasures are approved based on the results of animal studies.

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National Academies Press

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ISBN 10

0309102111

ISBN 13

9780309102117

Giving Full Measure to Countermeasures

Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents

By: National Research Council,Institute of Medicine,Board on Life Sciences,Medical Follow-up Agency,Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents

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Giving Full Measure to Countermeasures

Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents

In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations. According to a new congressionally mandated report from the Institute of Medicine and National Research Council of the National Academies, to successfully develop these drugs, vaccines, and other medical interventions against biowarfare agents, Congress should authorize the creation of a new agency within the Office of the Secretary of the U.S. Department of Defense. The committee recommended that Congress should improve liability protections for those who develop and manufacture these products, to stimulate willingness to invest in new research and development for biowarfare protection. Giving Full Measure to Countermeasures also identifies other challengesâ€"such as the need for appropriate animal models and laboratories equipped with high-level biosafety protectionsâ€"that will require attention if DoD efforts to develop new medical countermeasures are to be successful.

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164

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National Academies Press

Published Date

ISBN 10

0309091535

ISBN 13

9780309091534

Book's by Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents

Animal Models for Assessing Countermeasures to Bioterrorism Agents

Animal Models for Assessing Countermeasures to Bioterrorism Agents

Animal Models for Assessing Countermeasures to Bioterrorism Agents

Animal Models for Assessing Countermeasures to Bioterrorism Agents

Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents

Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents

Giving Full Measure to Countermeasures

Giving Full Measure to Countermeasures

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