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Board on Health Sciences Policy & Institute of Medicine: Understanding the Benefits and Risks of Pharmaceuticals
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 …
PDF
Angielski
DRM
€21.24
Board on Health Sciences Policy & Institute of Medicine: Addressing the Barriers to Pediatric Drug Development
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to …
PDF
Angielski
DRM
€21.14
Board on Health Sciences Policy & Institute of Medicine: Challenges for the FDA
As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protec …
PDF
Angielski
DRM
€31.58
Board on Health Sciences Policy & Institute of Medicine: Emerging Safety Science
In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (Di Masi and Grabowski, 2007). At the same …
PDF
Angielski
DRM
€35.96
Board on Health Sciences Policy & Institute of Medicine: Breakthrough Business Models
The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development becaus …
PDF
Angielski
DRM
€35.88
Board on Health Sciences Policy & Institute of Medicine: Accelerating the Development of Biomarkers for Drug Safety
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 dr …
PDF
Angielski
DRM
€21.19
Board on Health Sciences Policy & Institute of Medicine: Accelerating the Development of Biomarkers for Drug Safety
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 dr …
EPUB
Angielski
DRM
€30.81
Board on Health Sciences Policy & Forum on Medical and Public Health Preparedness for Catastrophic Events: Public Health Emergency Medical Countermeasures Enterprise
During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting natio …
PDF
Angielski
DRM
€43.22
Board on Health Sciences Policy & Institute of Medicine: Transforming Clinical Research in the United States
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 in …
PDF
Angielski
DRM
€35.96
Board on Health Sciences Policy & Forum on Medical and Public Health Preparedness for Catastrophic Events: Public Health Emergency Medical Countermeasures Enterprise
During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting natio …
EPUB
Angielski
DRM
€61.76
Board on Health Sciences Policy & Institute of Medicine: Building a National Framework for the Establishment of Regulatory Science for Drug Development
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 o …
PDF
Angielski
DRM
€21.19
Academy of Science of South Africa & Board on Health Sciences Policy: Emerging Threat of Drug-Resistant Tuberculosis in Southern Africa
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 …
PDF
Angielski
DRM
€35.30
Board on Health Care Services & Board on Health Sciences Policy: Direct-to-Consumer Genetic Testing
Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they o …
PDF
Angielski
DRM
€28.31
Board on Health Sciences Policy & Institute of Medicine: New Profile of Drug-Resistant Tuberculosis in Russia
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 diseas …
PDF
Angielski
DRM
€37.41
Board on Health Sciences Policy & Institute of Medicine: Transforming Clinical Research in the United States
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 in …
EPUB
Angielski
DRM
€51.34
Board on Health Sciences Policy & Institute of Medicine: Breakthrough Business Models
The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development becaus …
EPUB
Angielski
DRM
€51.35
Board on Health Sciences Policy & Institute of Medicine: Emerging Safety Science
In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (Di Masi and Grabowski, 2007). At the same …
EPUB
Angielski
DRM
€51.48
Board on Health Sciences Policy & Institute of Medicine: Addressing the Barriers to Pediatric Drug Development
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to …
EPUB
Angielski
DRM
€30.59
Board on Health Sciences Policy & Institute of Medicine: Challenges for the FDA
As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protec …
EPUB
Angielski
DRM
€45.89
Board on Health Sciences Policy & Institute of Medicine: Understanding the Benefits and Risks of Pharmaceuticals
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 …
EPUB
Angielski
DRM
€30.48
Board on Health Sciences Policy & Institute of Medicine: Adverse Drug Event Reporting
Recent concerns about the unexpected adverse effects of marketed drugs, such as COX-2 (cyclooxygenase-2) inhibitors or specific statins, raise concerns not only about reporting these events during pr …
EPUB
Angielski
DRM
€30.87
Board on Health Care Services & Board on Health Sciences Policy: Direct-to-Consumer Genetic Testing
Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they o …
EPUB
Angielski
DRM
€41.27
Board on Health Sciences Policy & Institute of Medicine: Building a National Framework for the Establishment of Regulatory Science for Drug Development
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 o …
EPUB
Angielski
DRM
€30.87
Academy of Science of South Africa & Board on Health Sciences Policy: Emerging Threat of Drug-Resistant Tuberculosis in Southern Africa
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 …
EPUB
Angielski
DRM
€50.11
Board on Health Sciences Policy & Forum on Medical and Public Health Preparedness for Catastrophic Events: Advancing Regulatory Science for Medical Countermeasure Development
Whether or not the United States has safe and effective medical countermeasuressuch as vaccines, drugs, and diagnostic toolsavailable for use during a disaster can mean the difference between life an …
PDF
Angielski
DRM
€45.69
Board on Health Sciences Policy & Forum on Medical and Public Health Preparedness for Catastrophic Events: Advancing Regulatory Science for Medical Countermeasure Development
Whether or not the United States has safe and effective medical countermeasuressuch as vaccines, drugs, and diagnostic toolsavailable for use during a disaster can mean the difference between life an …
EPUB
Angielski
DRM
€47.20
Board on Health Sciences Policy & Institute of Medicine: Public Engagement and Clinical Trials
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 the …
PDF
Angielski
DRM
€3.84
Board on Health Sciences Policy & Institute of Medicine: Public Engagement and Clinical Trials
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 the …
EPUB
Angielski
DRM
€42.46
Board on Health Sciences Policy & Institute of Medicine: Facing the Reality of Drug-Resistant Tuberculosis in India
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 …
PDF
Angielski
DRM
€3.79
Board on Health Sciences Policy & Institute of Medicine: Facing the Reality of Drug-Resistant Tuberculosis in India
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 …
EPUB
Angielski
DRM
€54.05
Board on Health Sciences Policy & Institute of Medicine: Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
The development and application of regulatory science – which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performanc …
PDF
Angielski
DRM
€3.84
Board on Health Sciences Policy & Institute of Medicine: Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
The development and application of regulatory science – which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performanc …
EPUB
Angielski
DRM
€32.28
Board on Health Sciences Policy & Institute of Medicine: New Profile of Drug-Resistant Tuberculosis in Russia
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 diseas …
EPUB
Angielski
DRM
€39.78
Board on Health Sciences Policy & Institute of Medicine: Envisioning a Transformed Clinical Trials Enterprise in the United States
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 h …
PDF
Angielski
DRM
€3.85
Board on Health Sciences Policy & Institute of Medicine: Envisioning a Transformed Clinical Trials Enterprise in the United States
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 h …
EPUB
Angielski
DRM
€51.47
Board on Health Sciences Policy & Institute of Medicine: Accelerating the Development of New Drugs and Diagnostics
Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite the …
PDF
Angielski
DRM
€3.86
Board on Health Sciences Policy & Institute of Medicine: Accelerating the Development of New Drugs and Diagnostics
Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite the …
EPUB
Angielski
DRM
€41.07
Board on Health Sciences Policy & Institute of Medicine: Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis
To effectively treat patients diagnosed with drug-resistant (DR) tuberculosis (TB) and protect the population from further transmission of this infectious disease, an uninterrupted supply of quality- …
PDF
Angielski
DRM
€3.83
Board on Health Sciences Policy & Institute of Medicine: Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis
To effectively treat patients diagnosed with drug-resistant (DR) tuberculosis (TB) and protect the population from further transmission of this infectious disease, an uninterrupted supply of quality- …
EPUB
Angielski
DRM
€46.32
Board on Health Care Services & Board on Health Sciences Policy: Sharing Clinical Research Data
Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical researc …
PDF
Angielski
DRM
€3.82
Board on Health Care Services & Board on Health Sciences Policy: Sharing Clinical Research Data
Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical researc …
EPUB
Angielski
DRM
€43.32
Board on Health Sciences Policy & Institute of Medicine: International Regulatory Harmonization Amid Globalization of Drug Development
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 safet …
PDF
Angielski
DRM
€3.82
Board on Health Sciences Policy & Institute of Medicine: International Regulatory Harmonization Amid Globalization of Drug Development
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 safet …
EPUB
Angielski
DRM
€42.22
Board on Health Sciences Policy & Institute of Medicine: Global Crisis of Drug-Resistant Tuberculosis and Leadership of China and the BRICS
Multidrug-resistant tuberculosis (TB) is caused by bacteria resistant to isoniazid and rifampicin, the two most effective first-line anti-TB drugs, originally developed and introduced in the 1950 and …
PDF
Angielski
DRM
€3.79
Board on Health Sciences Policy & Institute of Medicine: Global Crisis of Drug-Resistant Tuberculosis and Leadership of China and the BRICS
Multidrug-resistant tuberculosis (TB) is caused by bacteria resistant to isoniazid and rifampicin, the two most effective first-line anti-TB drugs, originally developed and introduced in the 1950 and …
EPUB
Angielski
DRM
€49.92
Board on Health Sciences Policy & Institute of Medicine: Large Simple Trials and Knowledge Generation in a Learning Health System
Randomized clinical trials (RCTs) are often referred to as the "gold standard" of clinical research. However, in its current state, the U.S. clinical trials enterprise faces substantial cha …
PDF
Angielski
DRM
€3.81
Board on Health Sciences Policy & Institute of Medicine: Large Simple Trials and Knowledge Generation in a Learning Health System
Randomized clinical trials (RCTs) are often referred to as the "gold standard" of clinical research. However, in its current state, the U.S. clinical trials enterprise faces substantial cha …
EPUB
Angielski
DRM
€39.65
Board on Health Sciences Policy & Institute of Medicine: Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products
Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors …
PDF
Angielski
DRM
€3.80
Board on Health Sciences Policy & Institute of Medicine: Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products
Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors …
EPUB
Angielski
DRM
€48.77
Board on Health Sciences Policy & Forum on Neuroscience and Nervous System Disorders: Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders
The Institute of Medicine (IOM) Forum on Neuroscience and Nervous System Disorders, in collaboration with the IOM Forum on Drug Discovery, Development, and Translation, convened a workshop on January …
PDF
Angielski
DRM
€3.79
Board on Health Sciences Policy & Forum on Neuroscience and Nervous System Disorders: Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders
The Institute of Medicine (IOM) Forum on Neuroscience and Nervous System Disorders, in collaboration with the IOM Forum on Drug Discovery, Development, and Translation, convened a workshop on January …
EPUB
Angielski
DRM
€46.21
Board on Global Health & Board on Health Sciences Policy: Rapid Medical Countermeasure Response to Infectious Diseases
Emerging infectious disease threats that may not have available treatments or vaccines can directly affect the security of the world’s health since these diseases also know no boundaries and will eas …
PDF
Angielski
DRM
€3.86
Board on Global Health & Board on Health Sciences Policy: Rapid Medical Countermeasure Response to Infectious Diseases
Emerging infectious disease threats that may not have available treatments or vaccines can directly affect the security of the world’s health since these diseases also know no boundaries and will eas …
EPUB
Angielski
DRM
€50.97
Board on Health Sciences Policy & Health and Medicine Division: Advancing the Discipline of Regulatory Science for Medical Product Development
The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, …
PDF
Angielski
DRM
€3.84
Board on Health Sciences Policy & Health and Medicine Division: Advancing the Discipline of Regulatory Science for Medical Product Development
The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, …
EPUB
Angielski
DRM
€42.46
Board on Health Sciences Policy & Health and Medicine Division: Deriving Drug Discovery Value from Large-Scale Genetic Bioresources
The process of discovering and developing a new drug or therapy is extremely costly and time consuming, and recently, it has been estimated that the creation of a new medicine costs on average more t …
PDF
Angielski
DRM
€3.85
Board on Health Sciences Policy & Health and Medicine Division: Deriving Drug Discovery Value from Large-Scale Genetic Bioresources
The process of discovering and developing a new drug or therapy is extremely costly and time consuming, and recently, it has been estimated that the creation of a new medicine costs on average more t …
EPUB
Angielski
DRM
€47.55
Board on Health Sciences Policy & Health and Medicine Division: Real-World Evidence Generation and Evaluation of Therapeutics
The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the c …
PDF
Angielski
DRM
€3.85
Board on Health Sciences Policy & Health and Medicine Division: Real-World Evidence Generation and Evaluation of Therapeutics
The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the c …
EPUB
Angielski
DRM
€57.91
Board on Health Sciences Policy & Health and Medicine Division: Enabling Precision Medicine
Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures …
PDF
Angielski
DRM
€3.85
Board on Health Sciences Policy & Health and Medicine Division: Enabling Precision Medicine
Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures …
EPUB
Angielski
DRM
€63.06
Board on Health Sciences Policy & Health and Medicine Division: Examining the Impact of Real-World Evidence on Medical Product Development
Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the …
PDF
Angielski
DRM
€3.85
Board on Health Sciences Policy & Health and Medicine Division: Examining the Impact of Real-World Evidence on Medical Product Development
Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the …
EPUB
Angielski
DRM
€70.42
Board on Health Sciences Policy & Institute of Medicine: Adverse Drug Event Reporting
Recent concerns about the unexpected adverse effects of marketed drugs, such as COX-2 (cyclooxygenase-2) inhibitors or specific statins, raise concerns not only about reporting these events during pr …
PDF
Angielski
DRM
€21.24
Board on Health Sciences Policy & Health and Medicine Division: Virtual Clinical Trials
Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clini …
EPUB
Angielski
DRM
€57.76
Board on Health Care Services & Board on Health Sciences Policy: Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting
Sharing knowledge is what drives scientific progress – each new advance or innovation in biomedical research builds on previous observations. However, for experimental findings to be broadly accepted …
EPUB
Angielski
DRM
€59.60
Board on Health Care Services & Board on Health Sciences Policy: Reflections on Sharing Clinical Trial Data
On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward …
EPUB
Angielski
DRM
€70.23
Board on Health Sciences Policy & Health and Medicine Division: Role of Digital Health Technologies in Drug Development
On March 24, 2020, a 1-day public workshop titled The Role of Digital Health Technologies in Drug Development was convened by the National Academies of Sciences, Engineering, and Medicine. This works …
EPUB
Angielski
DRM
€70.93
Board on Health Sciences Policy & Health and Medicine Division: Innovation in Drug Research and Development for Prevalent Chronic Diseases
Investment and innovation in drug research and development (RD) for highly prevalent chronic diseases has stalled in recent decades, despite half of all Americans living with at least one chronic dis …
EPUB
Angielski
DRM
€32.21
Board on Health Sciences Policy & Health and Medicine Division: Envisioning a Transformed Clinical Trials Enterprise for 2030
The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world …
EPUB
Angielski
DRM
€32.00
Board on Health Sciences Policy & Health and Medicine Division: Inclusion of Pregnant and Lactating Persons in Clinical Trials
Approximately 4 million pregnant people in the United States give birth annually, and 70 percent of these individuals take at least one prescription medication during their pregnancy. Yet, due to a n …
EPUB
Angielski
DRM
€24.44
Board on Global Health & Board on Health Sciences Policy: Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance
The use and misuse of antibiotics contributes to the rise in drug-resistant bacteria – a serious and worsening threat to human health. The development and use of rapid point-of-care diagnostics in th …
EPUB
Angielski
DRM
€24.13
Board on Health Care Services & Board on Health Sciences Policy: Drug Research and Development for Adults Across the Older Age Span
There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly underrepres …
EPUB
Angielski
DRM
€42.36
Board on Health Sciences Policy & Health and Medicine Division: Defining and Evaluating In-Home Drug Disposal Systems For Opioid Analgesics
The proper disposal of unused or expired prescription drugs, particularly controlled substances such as opioids, may help to prevent serious risk of nonmedical use or overdose. In June 2023, the Nati …
EPUB
Angielski
DRM
€23.14
Board on Health Sciences Policy & Board on Population Health and Public Health Practice: Preparing the Future Workforce in Drug Research and Development
Despite advances over the past several decades, the clinical trials enterprise has struggled to meet the needs of an increasingly diverse U.S. population. To help address this issue, a 2023 National …
EPUB
Angielski
DRM
€24.21
Board on Health Sciences Policy & Forum on Neuroscience and Nervous System Disorders: Adult Attention-Deficit/Hyperactivity Disorder
Attention deficit/hyperactivity disorder (ADHD) diagnosis and treatment among adults has increased over the past decade in the U.S. and globally. Evidence suggests adults with ADHD may be more likely …
EPUB
Angielski
DRM
€25.72
Board on Health Care Services & Board on Health Sciences Policy: Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics
The use of immune modulator therapeutics, a type of immunotherapy enhancing the body immune system response to cancer, was perceived as the beginning of a new era in cancer care. While still importan …
EPUB
Angielski
DRM
€22.81
Board on Health Care Services & Board on Health Sciences Policy: Optimizing Public-Private Partnerships for Clinical Cancer Research
Public-private partnerships (PPPs) are collaborations among public and private entities (e.g., government agencies, research institutions, nonprofit organizations, and industry organizations) that br …
EPUB
Angielski
DRM
€23.19
