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Pages 1-6

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From page 1...
... . Since, during the course of studying bioterrorism agents, it is not ethically appropriate to deliberately expose human subjects to bioterrorism agents, development of countermeasures relies on the ability of the scientific community to adequately test the effectiveness of countermeasures in animal models.
From page 2...
... CHARGE TO THE AUTHORING COMMITTEE The NIAID approached the National Research Council with a request that it prepare a short consensus report that articulates the difficulties of testing countermeasures to aerosolized bioterrorism agents in animals and identifies opportunities that can be pursued to improve current testing efforts. As part of this project, NIAID requested that a workshop be organized to bring together select agent researchers, including researchers from NIAID and U.S.
From page 3...
... So that future studies to test countermeasures can be compared and reproduced, the Committee recommends that specific parameters be measured and reported as part of a standard operating procedure adopted by researchers studying aerosolized bioterrorism agents. Researchers should measure particle properties including aerodynamic size, size distribution, geometric size and shape, electrical charge, chemical composition, irritancy, and mass concentration (mass of particles per unit mass of air)
From page 4...
... In addition, the Committee found a wide variation in published LD50 values in the available literature making the selection of dose difficult. Therefore, the Committee recommends obtaining statistical advice when designing an animal study to develop or test a countermeasure.
From page 5...
... In order to address the need for rapid development of countermeasures, while striking an appropriate balance between efficacy and safety, the Committee recommends that the FDA improve the process by which new countermeasures are approved by working with researchers to draft and finalize practical guidelines to ensure that applicants can effectively meet approval requirements.


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