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              Books by Forum on Drug Discovery, Development, and Translation

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              Total 27 jump to: go ‹ previous123next ›
              Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary

              Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Butler, Adrienne Stith; Begg, Heather

              • RRP: $35.99
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              Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals

              ISBN 9780309102766
              Released NZ 15 Sep 2007
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              Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary

              Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Medical and Public Health Preparedness for Catastrophic Events; Forum on Drug Discovery, Development, and Translation; Edited by Claiborne, Anne B.

              • RRP: $72.00
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              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 sc...ientific 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.
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              ISBN 9780309214902
              Released NZ 15 Jul 2011
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              Challenges for the FDA: The Future of Drug Safety: Workshop Summary

              Challenges for the FDA: The Future of Drug Safety: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Robinson, Sally; Pray, Leslie

              • RRP: $49.99
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              To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. This book deals with this symposium.

              ISBN 9780309109864
              Released NZ 15 Oct 2007
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              Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary

              Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Giffin, Robert B.; Lebovitz, Yeonwoo

              • RRP: $56.99
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              An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research... that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effecti
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              ISBN 9780309153324
              Released NZ 15 Dec 2010
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              Facing the Reality of Drug-Resistant Tuberculosis in India: Challenges and Potential Solutions: Summary of a Joint Workshop by the Institute of Medicine, the Indian National Science Academy, and the Indian Council of Medical Research

              Facing the Reality of Drug-Resistant Tuberculosis in India: Challenges and Potential Solutions: Summary of a Joint Workshop by the Institute of Medicine, the Indian National Science Academy, and the Indian Council of Medical Research (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Claiborne, Anne B.; Guenther, Rita S.

              • RRP: $68.00
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              An estimated 8.8 million people fell ill with tuberculosis (TB) in 2010 and 1.4 million died from the disease. Although antibiotics to treat TB were developed in the 1950s and are effective against a majority of TB cases, resistance to these antibiotics has emerged over the years..., resulting in the growing spread of multidrug-resistant (MDR) TB. Due to challenges in timely and accurate diagnosis of drug-resistant TB, length and tolerability of treatment regimens, and expense of second-line anti-TB drugs, effectively controlling the disease requires complex public health interventions. The IOM Forum on Drug Discovery, Development, and Translation held three international workshops to gather information from local experts around the world on the threat of drug resistant TB and how the challenges it presents can be met. Workshops were held in South Africa and Russia in 2010. The third workshop was held April 18-19, 2011, in New Delhi, India, in collaboration with the Indian National Science Academy and the Indian Council of Medical Research. The aim of the workshop was to highlight key challenges to controlling the spread of drug-resistant strains of TB in India and to discuss strategies for advancing and integrating local and international efforts to prevent and treat drug-resistant TB. This document summarizes the workshop. --Publisher's description.
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              ISBN 9780309219662
              Released NZ 15 Jul 2012
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              Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary

              Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary (Trade Paperback / Paperback)

              By on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Institute of Medicine; Edited by Lebovitz, Yeonwoo; English, Rebecca

              • RRP: $33.99
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              The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 20...10, to examine the state of regulatory science and to consider approaches for enhancing it. --Publisher's description.
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              ISBN 9780309158893
              Released NZ 15 Feb 2011
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              Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary

              Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary (Trade Paperback / Paperback)

              By Forum on Drug Discovery, Development, and Translation; on Health Sciences Policy, Board; Institute of Medicine; Edited by Pray, Leslie

              • RRP: $35.99
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              All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. ...Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.
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              ISBN 9780309107389
              Released NZ 15 Aug 2007
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              Emerging Safety Science: Workshop Summary

              Emerging Safety Science: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Giffin, Robert; Pool, Robert, Ph.D

              • RRP: $58.99
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              The average cost of developing a new approved drug is now estimated to be $1.3 billion. This title offers ways to select successful drug candidates earlier in development that could save billions of dollars, reduce the costs of drugs on the market, and increase the number of new ...drugs with improved safety profiles that are available to patients.
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              ISBN 9780309110129
              Released NZ 15 Apr 2008
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              Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary

              Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Claiborne, Anne B.; English, Rebecca A.

              • RRP: $79.00
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              There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to gener...ate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
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              ISBN 9780309253154
              Released NZ 15 Sep 2012
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              Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary

              Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Claiborne, Anne B.; English, Rebecca A.

              • RRP: $65.00
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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 gr...owing 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.
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              ISBN 9780309219297
              Released NZ 15 Dec 2011
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