64 Ebook di Development, and Translation Forum on Drug Discovery
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 …
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€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 …
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Inglese
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 …
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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 …
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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 …
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Inglese
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 …
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€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
Inglese
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 …
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Inglese
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 …
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Inglese
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
Inglese
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
Inglese
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 …
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Inglese
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 …
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Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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 …
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Inglese
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
Inglese
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
Inglese
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
Inglese
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 …
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Inglese
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
Inglese
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
Inglese
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 …
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Inglese
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
Inglese
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 …
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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
Inglese
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- …
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Inglese
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
Inglese
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
Inglese
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
Inglese
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 …
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Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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 …
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Inglese
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
Inglese
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 …
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Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
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 …
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Inglese
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
Inglese
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
Inglese
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
Inglese
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
Inglese
DRM
€21.24
