Anne B. Claiborne – författare
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20 produkter
Building a National Framework for the Establishment of Regulatory Science for Drug Development
Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2011
295 kr
Lägg i varukorg
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, 2010, to examine the …
Building a National Framework for the Establishment of Regulatory Science for Drug Development
Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2011
428 kr
Lägg i varukorg
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, 2010, to examine the …
Advancing Regulatory Science for Medical Countermeasure Development
Workshop Summary
Av Institute of Medicine, Board on Health Sciences Policy m. fl.
Häftad, 2011
485 kr
Lägg i varukorg
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 …
Advancing Regulatory Science for Medical Countermeasure Development
Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Forum on Medical and Public Health Preparedness for Catastrophic Events m. fl.
E-bok, 2011
615 kr
Lägg i varukorg
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 …
Advancing Regulatory Science for Medical Countermeasure Development
Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Forum on Medical and Public Health Preparedness for Catastrophic Events m. fl.
E-bok, 2011
641 kr
Lägg i varukorg
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 …
Public Engagement and Clinical Trials
New Models and Disruptive Technologies: Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2012
576 kr
Lägg i varukorg
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 …
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
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2012
749 kr
Lägg i varukorg
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 …
Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
Workshop Summary
Av Institute of Medicine, Board on Health Sciences Policy m. fl.
Häftad, 2012
309 kr
Lägg i varukorg
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 performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated …
Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2012
446 kr
Lägg i varukorg
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 performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated …
Envisioning a Transformed Clinical Trials Enterprise in the United States
Establishing an Agenda for 2020: Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2012
714 kr
Lägg i varukorg
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 generate timely and …
Accelerating the Development of New Drugs and Diagnostics
Maximizing the Impact of the Cures Acceleration Network: Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2012
559 kr
Lägg i varukorg
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 these opportunities, only a small fraction of investigational products are successfully developed into …
Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis
Workshop Summary
Av Institute of Medicine, Board on Health Sciences Policy m. fl.
Häftad, 2013
722 kr
Lägg i varukorg
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-assured (QA), second-line anti-TB drugs (SLDs) is necessary. Patients diagnosed with …
Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis
Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2013
642 kr
Lägg i varukorg
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-assured (QA), second-line anti-TB drugs (SLDs) is necessary. Patients diagnosed with …
Global Crisis of Drug-Resistant Tuberculosis and Leadership of China and the BRICS
Challenges and Opportunities: Summary of a Joint Workshop by the Institute of Medicine and the Institute of Microbiology, Chinese Academy of Sciences
Av Institute of Medicine, Board on Health Sciences Policy m. fl.
Häftad, 2014
460 kr
Lägg i varukorg
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 1960s. Since 2008, the Forum on Drug Discovery, Development, and Translation of the Institute of …
Global Crisis of Drug-Resistant Tuberculosis and Leadership of China and the BRICS
Challenges and Opportunities: Summary of a Joint Workshop by the Institute of Medicine and the Institute of Microbiology, Chinese Academy of Sciences
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2014
696 kr
Lägg i varukorg
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 1960s. Since 2008, the Forum on Drug Discovery, Development, and Translation of the Institute of …
Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products
Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2014
678 kr
Lägg i varukorg
Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process …
Global Health Risk Framework
Research and Development of Medical Products: Workshop Summary
Av Board on Health Sciences Policy, Institute of Medicine m. fl.
E-bok, 2016
642 kr
Lägg i varukorg
Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, …
Advancing the Discipline of Regulatory Science for Medical Product Development
An Update on Progress and a Forward-Looking Agenda: Workshop Summary
Av and Medicine National Academies of Sciences, Engineering, Health and Medicine Division m. fl.
Häftad, 2016
651 kr
Lägg i varukorg
The field of endeavors known as a /regulatory sciencea has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could …
Advancing the Discipline of Regulatory Science for Medical Product Development
An Update on Progress and a Forward-Looking Agenda: Workshop Summary
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2016
589 kr
Lägg i varukorg
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, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform …
Real-World Evidence Generation and Evaluation of Therapeutics
Proceedings of a Workshop
Av and Translation Forum on Drug Discovery, Development, Board on Health Sciences Policy m. fl.
E-bok, 2017
803 kr
Lägg i varukorg
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 context of this wealth of real-world data could be numerous and varied, ranging from the ability to …
