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    Default Animal Models for Assessing Countermeasures to Bioterrorism Agents

    Animal Models for Assessing Countermeasures to Bioterrorism Agents
    Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents; National Research Council








    NAS Press
    2011
    ISBN: 0309219094 9780309219099
    153 pages
    PDF
    3 MB



    Animal Models for Assessing Countermeasures This issue 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 also evaluates alternatives to the use of animal models based on the premise of the Three Rs.


    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.




    Contents


    SUMMARY
    1 INTRODUCTION
    The Nature of Threat
    Addressing the Unknown Threat through the Transformational Medical Technologies Initiative
    Statement of Task
    Approach by the Committee
    References
    2 EVALUATION OF CURRENT AND FUTURE TMT-USED ANIMAL MODELS
    Animal Models Are Analogous, Not Homologous Systems
    Considerations for Animal Models for Countermeasure Development
    Filoviruses
    Tularemia
    Anthrax
    Lessons Learned from Developing Animal Models for Therapeutic Purposes against Biothreat Agents
    References
    3 ETHICAL AND REGULATORY CHALLENGES IN THE DEVELOPMENT OF COUNTERMEASURES
    History of the Animal Rule and Ethical Considerations
    The Low Approval Rate to Date under the Animal Rule
    Regulation of Drug Development
    References
    4 DEVELOPING NEW ANIMAL MODELS FOR BIODEFENSE RESEARCH
    Use of Human Data to Improve the Value of Animal Models
    Interactions with the Food and Drug Administration
    “Validation” of Animal Models for Biodefense Research
    Comparative Biology and Compartmentalization in Animal Model Development
    Optimizing Current Animal Models
    References
    5 ALTERNATIVE APPROACHES TO ANIMAL TESTING FOR BIODEFENSE COUNTERMEASURES
    General Principles of Alternative Approaches
    Animal Efficacy Studies Are Clinical Trials
    In Vitro Tools and Replacement Strategies
    Promises and Challenges for the Future
    References,
    APPENDICES
    A THE ANIMAL RULE
    B DRAFT GUIDANCE TO INDUSTRY: ANIMAL MODELS – ESSENTIAL ELEMENTS TO ADDRESS EFFICACY UNDER THE ANIMAL RULE
    C DEVELOPING ANIMAL MODELS FOR USE IN ANIMAL RULE LICENSURE: THE NIAID APPROACH
    D PRESENTATIONS TO THE COMMITTEE
    E STATEMENT OF TASK
    F ABOUT THE AUTHORS



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    Last edited by Micotil; 15th December 2011 at 10:12 AM.
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