Animal Models For Assessing Countermeasures To Bioterrorism Agents
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Animal Models For Assessing Countermeasures To Bioterrorism Agents
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2012-01-09
Animal Models For Assessing Countermeasures To Bioterrorism Agents written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-09 with Science categories.
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.
Overcoming Challenges To Develop Countermeasures Against Aerosolized Bioterrorism Agents
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2006-09-07
Overcoming Challenges To Develop Countermeasures Against Aerosolized Bioterrorism Agents written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-09-07 with Political Science categories.
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.
Biodefense Research Methodology And Animal Models
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Author : James R. Swearengen
language : en
Publisher: CRC Press
Release Date : 2012-02-16
Biodefense Research Methodology And Animal Models written by James R. Swearengen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-02-16 with Medical categories.
Significant advances have been made in animal model development for biological research since the publication of the first edition of this volume, and the ramifications of the FDA's Animal Efficacy Rule have become better understood in the scientific community. With each chapter completely updated with the latest research findings, Biodefense Resea
Advancing Disease Modeling In Animal Based Research In Support Of Precision Medicine
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2018-05-29
Advancing Disease Modeling In Animal Based Research In Support Of Precision Medicine written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-29 with Science categories.
Precision medicine is focused on the individual and will require the rapid and accurate identification and prioritization of causative factors of disease. To move forward and accelerate the delivery of the anticipated benefits of precision medicine, developing predictable, reproducible, and reliable animal models will be essential. In order to explore the topic of animal-based research and its relevance to precision medicine, the National Academies of Sciences, Engineering, and Medicine convened a 2-day workshop on October 5 and 6, 2017. The workshop was designed to focus on the development, implementation, and interpretation of model organisms to advance and accelerate the field of precision medicine. Participants examined the extent to which next-generation animal models, designed using patient data and phenotyping platforms targeted to reveal and inform disease mechanisms, will be essential to the successful implementation of precision medicine. This publication summarizes the presentations and discussions from the workshop.
Advancing Regulatory Science For Medical Countermeasure Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-08-27
Advancing Regulatory Science For Medical Countermeasure Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-27 with Medical categories.
Whether or not the United States has safe and effective medical countermeasures-such as vaccines, drugs, and diagnostic tools-available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures. During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools. Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations.
Defense Against Biological Attacks
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Author : Sunit K. Singh
language : en
Publisher: Springer
Release Date : 2019-03-30
Defense Against Biological Attacks written by Sunit K. Singh and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-30 with Medical categories.
This first volume of a two-volume set describes general aspects, such as the historical view on the topic, the role of information distribution and preparedness of health-care systems and preparedness in emergency cases. Part two describes and discusseses in detail the pathogens and toxins that are potentially used for biological attacks. As such, the book is a valuable resource for faculties engaged in molecular biology, genetic engineering, neurology, biodefense, biosafety & biosecurity, virology, and infectious disease programs, as well as professional medical research organizations.
Principles Of Animal Research For Graduate And Undergraduate Students
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Author : Mark A. Suckow
language : en
Publisher: Academic Press
Release Date : 2016-11-16
Principles Of Animal Research For Graduate And Undergraduate Students written by Mark A. Suckow and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-16 with Psychology categories.
Principles of Animal Research is the first publication to offer a broad look at animal research science for a student, early researcher, or technician. Offering guidance for all aspects of the research experience, including the research and development of a thesis, model selection, experimental design, IACUC protocol preparation, and animal husbandry and technical procedural needs, the book is a necessary addition to every student, technician, and researcher's education. - Provides background material for students to understand the broader backdrop against which animal research is undertaken - Includes ethical and regulatory information - Covers commonly used animal models and the process to choose a model for biomedical research
Sequence Based Classification Of Select Agents
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2010-11-08
Sequence Based Classification Of Select Agents written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-11-08 with Nature categories.
Select Agents are defined in regulations through a list of names of particularly dangerous known bacteria, viruses, toxins, and fungi. However, natural variation and intentional genetic modification blur the boundaries of any discrete Select Agent list based on names. Access to technologies that can generate or 'synthesize' any DNA sequence is expanding, making it easier and less expensive for researchers, industry scientists, and amateur users to create organisms without needing to obtain samples of existing stocks or cultures. This has led to growing concerns that these DNA synthesis technologies might be used to synthesize Select Agents, modify such agents by introducing small changes to the genetic sequence, or create entirely new pathogens. Amid these concerns, the National Institutes of Health requested that the Research Council investigate the science and technology needed to replace the current Select Agent list with an oversight system that predicts if a DNA sequence could be used to produce an organism that should be regulated as a Select Agent. A DNA sequence-based system to better define when a pathogen or toxin is subject to Select Agent regulations could be developed. This could be coupled with a 'yellow flag' system that would recognize requests to synthesize suspicious sequences and serve as a reference to anyone with relevant questions, allowing for appropriate follow-up. Sequence-Based Classification of Select Agents finds that replacing the current list of Select Agents with a system that could predict if fragments of DNA sequences could be used to produce novel pathogens with Select Agent characteristics is not feasible. However, it emphasized that for the foreseeable future, any threat from synthetic biology and synthetic genomics is far more likely to come from assembling known Select Agents, or modifications of them, rather than construction of previously unknown agents. Therefore, the book recommends modernizing the regulations to define Select Agents in terms of their gene sequences, not by their names, and called this 'sequence-based classification.'
Design Implementation Monitoring And Sharing Of Performance Standards For Laboratory Animal Use
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-12-04
Design Implementation Monitoring And Sharing Of Performance Standards For Laboratory Animal Use written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-12-04 with Science categories.
In order to better understand the critical issues pertaining to the concept of performance standards for laboratory animal use, the Institute for Laboratory Animal Research Roundtable on Science and Welfare in Laboratory Animal Use held a public workshop on April 20-21, 2015. The purpose of the workshop was to promote the appropriate and responsible care of animals in research, to provide a balanced and civil forum for discussion and collaboration, and to help build transparency and trust among stakeholders. Participants addressed the challenges of defining, developing, implementing, assessing, and validating performance standards to ensure "optimal practices, management, and operations." This report summarizes the presentations and discussions from the workshop.
Viral Hemorrhagic Fevers
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Author : Sunit K. Singh
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Viral Hemorrhagic Fevers written by Sunit K. Singh and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Viral hemorrhagic fevers have captured the imagination of the public and made their way into popular books and movies by virtue of their extreme virulence and mysterious origins. Since 2001, concerns have grown about the potential use of many hemorrhagic fever viruses as biological weapons. This has led to a resurgence in research to develop improv