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Book
Advancing regulatory science for medical countermeasure development
Authors: --- --- ---
ISBN: 0309214904 9786613253545 1283253542 0309214912 9780309214919 9781283253543 9780309214902 0309214939 6613253545 Year: 2011 Publisher: Washington, D.C. Natlional Academies Press

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Abstract

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"--Publisher's description.


Book
Public engagement and clinical trials
Authors: --- --- ---
ISBN: 0309219299 9786613311962 1283311968 0309219302 9780309219297 9780309219303 0309219329 Year: 2011 Publisher: Washington, D.C. National Academies Press

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Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.


Book
Envisioning a transformed clinical trials enterprise in the United States
Authors: --- --- ---
ISBN: 0309253152 0309253160 1283636360 0309253187 9780309253154 9780309253161 Year: 2012 Publisher: Washington, D.C. National Academies Press


Book
Emerging threat of drug-resistant tuberculosis in southern Africa
Authors: --- --- --- ---
ISBN: 0309160243 0309160251 9786613081544 1283081547 9780309160254 661308154X 9780309160247 9781283081542 0309211603 9780309211604 Year: 2011 Publisher: Washington, D.C. National Academies Press

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"Tuberculosis (TB) kills approximately 4,500 people worldwide every day. While most cases of TB can be treated with antibiotics, some strains have developed drug resistance that makes their treatment more expensive, more toxic and less effective for the patient. The IOM Forum on Drug Discovery, Development, and Translation and the Academy of Science of South Africa held a workshop to discuss ways to fight the growing threat of drug-resistant TB."--Publisher's website.


Book
The new profile of drug-resistant tuberculosis in Russia
Authors: --- --- --- ---
ISBN: 0309162971 9786613213358 1283213354 030916298X 9780309162982 9781283213356 9780309162975 6613213357 0309225051 9780309225052 Year: 2011 Publisher: Washington, D.C. National Academies Press

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Abstract

An estimated 2 billion people, one third of the global population, are infected with Mycobacterium tuberculosis, the bacterium that causes tuberculosis. Spread through the air, this infectious disease killed 1.7 million in 2009, and is the leading killer of people with HIV. Tuberculosis (TB) is also a disease of poverty--the vast majority of tuberculosis deaths occur in the developing world. Exacerbating the devastation caused by TB is the growing threat of drug-resistant forms of the disease in many parts of the world. Drug-resistant tuberculosis presents a number of significant challenges in terms of controlling its spread, diagnosing patients quickly and accurately, and using drugs to treat patients effectively. In Russia in recent decades, the rise of these strains of TB, resistant to standard antibiotic treatment, has been exacerbated by the occurrence of social, political, and economic upheavals. The Institute of Medicine (IOM) Forum on Drug Discovery, Development, and Translation, in conjunction with the Russian Academy of Medical Sciences held a workshop to discuss ways to fight the growing threat of drug-resistant TB. This book presents information from experts on the nature of this threat and how it can be addressed by exploring various treatment and diagnostic options.


Book
The global crisis of drug-resistant tuberculosis and leadership of China and the BRICS
Authors: --- --- --- --- --- et al.
ISBN: 0309285968 0309285976 9780309285964 9780309285971 0309285992 Year: 2014 Publisher: Washington, D.C.

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