LEADER 04639nam 2200685 a 450 001 9910961776903321 005 20200520144314.0 010 $a9786613527127 010 $a9780309219129 010 $a0309219124 010 $a9781280123269 010 $a1280123265 010 $a9780309219105 010 $a0309219108 035 $a(CKB)2550000000087420 035 $a(EBL)3564249 035 $a(SSID)ssj0000644789 035 $a(PQKBManifestationID)11408333 035 $a(PQKBTitleCode)TC0000644789 035 $a(PQKBWorkID)10680380 035 $a(PQKB)10928130 035 $a(MiAaPQ)EBC3564249 035 $a(Au-PeEL)EBL3564249 035 $a(CaPaEBR)ebr10531107 035 $a(CaONFJC)MIL352712 035 $a(OCoLC)785779562 035 $a(Perlego)4738806 035 $a(EXLCZ)992550000000087420 100 $a20120305d2011 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aAnimal models for assessing countermeasures to bioterrorism agents /$fCommittee on Animal Models for Assessing Countermeasures to Bioterrorism Agents 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$d2011 215 $a1 online resource (151 p.) 300 $aDescription based upon print version of record. 311 08$a9780309219099 311 08$a0309219094 320 $aIncludes bibliographical references. 327 $a""Front matter""; ""Acknowledgments""; ""Contents""; ""Summary""; ""1 Introduction""; ""2 Evaluation of Current and Future TMT-Used Animal Models""; ""3 Ethical and Regulatory Challenges in the Development of Countermeasures""; ""4 Developing New Animal Models for Biodefense Research""; ""5 Alternative Approaches to Animal Testing for Biodefense Countermeasures""; ""Appendix A: The Animal Rule""; ""Appendix B: Draft Guidance for Industry""; ""Appendix C: Developing Animal Models for Use in Animal Rule Licensure: The NIAID Approach""; ""Appendix D: Presentations to the Committee"" 327 $a""Appendix E: Statement of Task""""Appendix F: About the Authors"" 330 $a"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"--Publisher's description. 606 $aBioterrorism 606 $aBiology, Experimental 606 $aAnimal models in research 615 0$aBioterrorism. 615 0$aBiology, Experimental. 615 0$aAnimal models in research. 676 $a570 712 02$aNational Research Council (U.S.) 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910961776903321 996 $aAnimal models for assessing countermeasures to bioterrorism agents$94356513 997 $aUNINA