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Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: Workshop Summary
and TranslationCurrent price €47.49Original price €49.99Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including t...
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Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop
and Medicine€31.99The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approache...
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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary
and Translation€33.99The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to ...
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Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary
and Medicine€42.99The field of endeavors known as regulatory science has grown out of the need to link and integrate knowledge within and among basic science researc...
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Large Simple Trials and Knowledge Generation in a Learning Health System: Workshop Summary
and TranslationCurrent price €39.89Original price €41.99Randomized clinical trials (RCTs) are often referred to as the gold standard of clinical research. However, in its current state, the U.S. clinical...
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Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary
and TranslationCurrent price €40.84Original price €42.99Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innova...
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Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary
and TranslationCurrent price €44.64Original price €46.99To effectively treat patients diagnosed with drug-resistant (DR) tuberculosis (TB) and protect the population from further transmission of this inf...
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Adult Attention-Deficit/Hyperactivity Disorder: Diagnosis, Treatment, and Implications for Drug Development: Proceedings of a Workshop
and Medicine€25.99Attention deficit/hyperactivity disorder (ADHD) diagnosis and treatment among adults has increased over the past decade in the U.S. and globally. E...
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Preparing the Future Workforce in Drug Research and Development: Proceedings of a Workshop
and Medicine€23.99Despite advances over the past several decades, the clinical trials enterprise has struggled to meet the needs of an increasingly diverse U.S. popu...
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Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary
and Translation€29.99The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough t...
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Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance: Proceedings of a Workshop
and MedicineCurrent price €22.79Original price €23.99The use and misuse of antibiotics contributes to the rise in drug-resistant bacteria - a serious and worsening threat to human health. The developm...
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Rapid Medical Countermeasure Response to Infectious Diseases: Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships: Workshop Summary
and MedicineCurrent price €49.39Original price €51.99Emerging infectious disease threats that may not have available treatments or vaccines can directly affect the security of the world's health since...
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Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary
and TranslationCurrent price €49.39Original price €51.99An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between ...
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Real-World Evidence Generation and Evaluation of Therapeutics: Proceedings of a Workshop
and Medicine€56.99The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Poten...
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International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary
and TranslationCurrent price €40.84Original price €42.99The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products a...
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Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting: Proceedings of a Workshop
and Medicine€61.50Sharing knowledge is what drives scientific progress - each new advance or innovation in biomedical research builds on previous observations. Howev...
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Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series
and Medicine€66.99Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RC...
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Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop
and IndependenceCurrent price €40.84Original price €42.99There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years a...
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Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop
and MedicineCurrent price €59.84Original price €62.99Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy...
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Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop
and MedicineCurrent price €22.79Original price €23.99The use of immune modulator therapeutics, a type of immunotherapy enhancing the body immune system response to cancer, was perceived as the beginni...
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The Emerging Threat of Drug-Resistant Tuberculosis in Southern Africa: Global and Local Challenges and Solutions: Summary of a Joint Workshop by the Institute of Medicine and the Academy of Science...
Academy of Science of South AfricaCurrent price €48.44Original price €50.99Tuberculosis (TB) kills approximately 4,500 people worldwide every day. While most cases of TB can be treated with antibiotics, some strains have d...
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The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary
and TranslationCurrent price €56.69Original price €62.99During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medic...
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Deriving Drug Discovery Value from Large-Scale Genetic Bioresources: Proceedings of a Workshop
and MedicineCurrent price €44.64Original price €46.99The process of discovering and developing a new drug or therapy is extremely costly and time consuming, and recently, it has been estimated that th...
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Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop
and MedicineCurrent price €67.44Original price €70.99On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Shari...
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