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  • 11
    Online Resource
    Online Resource
    Challenges for the FDA : the future of drug safety : workshop summary (2007)
    Washington, DC : National Academies Press
    Details
    UID:
    (DE-627)1773237012
    Format: 1 Online-Ressource (xvii, 109 p.) , ill. , 23 cm.
    ISBN: 9780309109864 , 0309109868
    Note: Includes bibliographical references (p. 78-79)
    Language: English
    Keywords: Congress
    URL: teilw. kostenfrei
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    Online Resource
    BSZ
    GBV
  • 12
    Online Resource
    Online Resource
    Strengthening a workforce for innovative regulatory science in therapeutics development : workshop summary (2012)
    Washington, D.C. : National Academies Press
    Details
    UID:
    (DE-627)1773222937
    Format: 1 online resource (PDF file (xv, 102 p.)) , ill.
    ISBN: 9780309222143 , 0309222141
    Content: The Forum (Forum on Drug Discovery, Development, and Translation) convened a workshop on September 20-21, 2011, entitled "Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development." This workshop provided a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as articulated in the 2010 workshop on regulatory science. The broad objectives of the workshop were (1) to consider opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce and (2) to examine specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA (Food and Drug Administration). Specific objectives included the following:1. Define and discuss the current regulatory science workforce, with particular attention to the disciplines involved, professional training opportunities, and gaps in the essential components of this workforce.2. Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development.3. Examine the application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening the national regulatory science workforce.4. Explore the resources and stakeholder engagement needed, not only within FDA and other federal agencies but throughout the extramural sector, to build the discipline and establish career paths in regulatory science for therapeutics development.
    Note: Includes bibliographical references. - Description based on online resource; title from PDF title page (viewed June. 25, 2012)
    Language: English
    Keywords: Congress
    URL: teilw. kostenfrei
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  • 13
    Online Resource
    Online Resource
    Addressing the threat of drug-resistant tuberculosis : a realistic assessment of the challenge : workshop summary (2009)
    Washington, D.C : National Academies Press
    Details
    UID:
    (DE-627)1655551124
    Format: Online Ressource (xvi, 235 p.) , ill. (some col.), maps (some col.)
    Edition: Online-Ausg.
    ISBN: 9780309130455 , 030913045X
    Content: "Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs--a major and growing threat worldwide. The Institute of Medicine's Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions."--Publisher's website
    Note: "The Institute of Medicine's (IOM's) Forum on Drug Discovery, Development, and Translation held a workshop in Washington, DC, on November 5, 2008"--P. 2. - Includes bibliographical references. - Description based on print version record
    Additional Edition: 0309130441
    Additional Edition: 9780309130448
    Additional Edition: 9780309130448
    Additional Edition: Erscheint auch als Druck-Ausgabe Addressing the threat of drug-resistant tuberculosis Washington, D.C : National Academies Press, 2009 9780309130448
    Language: English
    Keywords: Congress ; Electronic books ; Konferenzschrift
    URL: lizenzpflichtig
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  • 14
    Online Resource
    Online Resource
    Addressing the threat of drug-resistant tuberculosis : a realistic assessment of the challenge : workshop summary (2009)
    Washington, D.C. : National Academies Press
    Details
    UID:
    (DE-604)BV043117542
    Format: 1 Online-Ressource (xvi, 235 p.)
    ISBN: 030913045X , 9780309130455
    Note: "The Institute of Medicine's (IOM's) Forum on Drug Discovery, Development, and Translation held a workshop in Washington, DC, on November 5, 2008"--P. 2 , Includes bibliographical references , Introduction -- The global spread of multidrug-resistant and extensively drug-resistant tuberculosis -- MDR TB transmission, HIV coinfection, and transmission control -- Diagnosis -- Infrastructure and health care delivery systems -- Global systems for the purchase and delivery of TB drugs -- Research on the global control of TB: understanding the role of drugs, vaccines, and funding -- Strategies for confronting the global MDR and XDR TB crisis , "Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs--a major and growing threat worldwide. The Institute of Medicine's Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions."--Publisher's website
    Additional Edition: Erscheint auch als Druck-Ausgabe, Paperback ISBN 0-309-13044-1
    Additional Edition: Erscheint auch als Druck-Ausgabe, Paperback ISBN 978-0-309-13044-8
    Language: English
    Keywords: Konferenzschrift
    URL: Volltext
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    Online Resource
    Online Access
    BVB
  • 15
    Online Resource
    Online Resource
    Adverse drug event reporting : the roles of consumers and health-care professionals ; workshop summary (2007)
    Washington, D.C : National Academies Press
    Details
    UID:
    (DE-627)646970704
    Format: Online-Ressource (xii, 70 p) , ill
    Edition: Online-Ausg. Palo Alto, Calif ebrary 2009 Electronic reproduction; Available via World Wide Web
    ISBN: 0309102766 , 9780309102766
    Content: Introduction -- Current adverse event reporting systems -- Active surveillance systems -- Consumer involvement in reporting adverse events -- Drug-drug interactions -- Drug labels
    Note: Summary of a workshop which took place on November 3 and 4, 2005, in Washington, D.C , Includes bibliographical references , Electronic reproduction; Available via World Wide Web
    Additional Edition: Print version Adverse drug event reporting Washington, D.C : National Academies Press, ©2007
    Language: English
    Keywords: Congresses
    URL: Volltext
    URL: Volltext
    URL: Volltext
    URL: Volltext
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    Online Resource
    Online Access
    GBV
  • 16
    Online Resource
    Online Resource
    International regulatory harmonization amid globalization of drug development : workshop summary (2013)
    Washington, D.C. : National Academies Press
    Details
    UID:
    (DE-627)1773218506
    Format: 1 online resource
    ISBN: 9780309284790 , 0309284791
    Content: The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.
    Note: Title from PDF title page. - Includes bibliographical references. - Description based on version viewed January 28, 2014
    Language: English
    Keywords: Congress
    URL: teilw. kostenfrei
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  • 17
    Online Resource
    Online Resource
    Enabling discovery, development, and translation of treatments for cognitive dysfunction in depression : workshop summary (2015)
    Washington, DC : National Academies Press
    Details
    UID:
    (DE-627)1773210238
    Format: 1 online resource (1 PDF file (xii, 77 pages)) , illustrations
    Content: Major depressive disorder (MDD) is recognized worldwide as a major cause of disability, morbidity, and mortality. According to the World Health Organization, unipolar depressive disorders affect more than 150 million people around the world and represent the leading cause of years lost due to disability among both men and women. In the United States alone, nearly 8 percent of persons over the age of 12 report current depression. MDD has long been defined primarily as a mood disorder. However, more recently people have begun to recognize effects on cognition as a major contributor to the disablement that accompanies depression and to consider this an underrecognized treatment target for depression. To explore how best to enable the discovery, development, and translation of treatments for cognitive dysfunction in depression, including a focus on the regulatory path forward, the Institute of Medicine's Forum on Neuroscience and Nervous Disorders convened key stakeholders at a workshop in February 2015. This report summarizes the presentations from expert speakers and discussions among workshop participants.
    Note: Title from PDF title page. - Includes bibliographical references. - Description based on version viewed December 21, 2015
    Language: English
    Keywords: Congress
    URL: teilw. kostenfrei
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  • 18
    Online Resource
    Online Resource
    Accelerating the development of biomarkers for drug safety : workshop summary (2009)
    Washington, D.C. : National Academies Press
    Details
    UID:
    (DE-627)1773232371
    Format: 1 Online-Ressource (xv, 83 p.) , ill. , 23 cm.
    ISBN: 9780309131247 , 0309131243
    Content: "Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held 'Assessing and Accelerating Development of Biomarkers for Drug Safety,' a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development."--Publisher's website.
    Note: Errata sheet inserted. - Includes bibliographical references (p. 55-57)
    Language: English
    Keywords: Congress
    URL: teilw. kostenfrei
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  • 19
    Online Resource
    Online Resource
    Accelerating the development of biomarkers for drug safety : workshop summary (2009)
    Washington, D.C. : National Academies Press
    Details
    UID:
    (DE-627)1773233130
    Format: 1 Online-Ressource (xv, 83 p.) , ill. , 23 cm.
    ISBN: 9780309131247 , 0309131243
    Content: "Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held 'Assessing and Accelerating Development of Biomarkers for Drug Safety,' a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development."--Publisher's website.
    Note: Errata sheet inserted. - Includes bibliographical references (p. 55-57)
    Language: English
    Keywords: Congresses
    URL: teilw. kostenfrei
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  • 20
    Online Resource
    Online Resource
    Accelerating the development of biomarkers for drug safety : workshop summary (2009)
    Washington, D.C. : National Academies Press
    Details
    UID:
    (DE-604)BV043132598
    Format: 1 Online-Ressource (xiv, 84 p.)
    ISBN: 0309131251 , 1282272659 , 9780309131247 , 9780309131254 , 9781282272651
    Note: "Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development." , Includes bibliographical references , Introduction -- Overview Of key issues -- Cardiac safety biomarkers -- Assessing and predicting kidney safety -- Biomarkers of acute idiosyncratic hepatocellular injury in clinical trials -- Future considerations
    Additional Edition: Erscheint auch als Druck-Ausgabe, Paperback ISBN 0-309-13124-3
    Additional Edition: Erscheint auch als Druck-Ausgabe, Paperback ISBN 978-0-309-13124-7
    Language: English
    Keywords: Konferenzschrift
    URL: Volltext
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    Online Resource
    Online Access
    BVB
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