Drug Research And Development For Adults Across The Older Age Span

Author : National Academies of Sciences Engineering and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services,National Cancer Policy Forum,Forum on Drug Discovery Development and Translation,Forum on Aging Disability and Independence
Publisher : Unknown
Page : 128 pages
File Size : 45,6 Mb
Release : 2021-10-22
Category : Electronic
ISBN : 0309685680

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Drug Research and Development for Adults Across the Older Age Span by National Academies of Sciences Engineering and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services,National Cancer Policy Forum,Forum on Drug Discovery Development and Translation,Forum on Aging Disability and Independence Pdf

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 underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population. On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations over age 65. This publication summarizes the presentation and discussion of the workshop.

Author : Sven Stegemann
Publisher : Springer
Page : 771 pages
File Size : 51,9 Mb
Release : 2016-10-20
Category : Medical
ISBN : 9783319430997

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Developing Drug Products in an Aging Society by Sven Stegemann Pdf

This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Page : 107 pages
File Size : 41,7 Mb
Release : 2014-02-06
Category : Medical
ISBN : 9780309292498

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Improving and Accelerating Therapeutic Development for Nervous System Disorders by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services
Publisher : National Academies Press
Page : 103 pages
File Size : 49,7 Mb
Release : 2020-01-27
Category : Medical
ISBN : 9780309498517

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The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services Pdf

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
Publisher : National Academies Press
Page : 432 pages
File Size : 53,9 Mb
Release : 2012-10-13
Category : Medical
ISBN : 9780309225496

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Safe and Effective Medicines for Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) Pdf

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publisher : National Academies Press
Page : 442 pages
File Size : 50,9 Mb
Release : 2011-04-03
Category : Medical
ISBN : 9780309158060

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Rare Diseases and Orphan Products by Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Pdf

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Author : National Academies Of Sciences Engineeri,National Academies of Sciences Engineering and Medicine,Health And Medicine Division,Board On Health Sciences Policy,Forum on Drug Discovery Development and Translation
Publisher : National Academies Press
Page : 128 pages
File Size : 47,9 Mb
Release : 2022-08-09
Category : Medical
ISBN : 0309269288

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Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop by National Academies Of Sciences Engineeri,National Academies of Sciences Engineering and Medicine,Health And Medicine Division,Board On Health Sciences Policy,Forum on Drug Discovery Development and Translation Pdf

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 settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands. Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.

Author : Institute of Medicine,Board on Health Care Services,Committee on the Future Health Care Workforce for Older Americans
Publisher : National Academies Press
Page : 317 pages
File Size : 52,8 Mb
Release : 2008-09-27
Category : Medical
ISBN : 9780309115872

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Retooling for an Aging America by Institute of Medicine,Board on Health Care Services,Committee on the Future Health Care Workforce for Older Americans Pdf

As the first of the nation's 78 million baby boomers begin reaching age 65 in 2011, they will face a health care workforce that is too small and woefully unprepared to meet their specific health needs. Retooling for an Aging America calls for bold initiatives starting immediately to train all health care providers in the basics of geriatric care and to prepare family members and other informal caregivers, who currently receive little or no training in how to tend to their aging loved ones. The book also recommends that Medicare, Medicaid, and other health plans pay higher rates to boost recruitment and retention of geriatric specialists and care aides. Educators and health professional groups can use Retooling for an Aging America to institute or increase formal education and training in geriatrics. Consumer groups can use the book to advocate for improving the care for older adults. Health care professional and occupational groups can use it to improve the quality of health care jobs.

Author : Anonim
Publisher : Unknown
Page : 108 pages
File Size : 42,9 Mb
Release : 2007
Category : Age distribution (Demography)
ISBN : WISC:89119734713

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Growing Older in America by Anonim Pdf

Author : National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Health and Medicine Division,Board on Behavioral, Cognitive, and Sensory Sciences,Board on Health Sciences Policy,Committee on the Health and Medical Dimensions of Social Isolation and Loneliness in Older Adults
Publisher : National Academies Press
Page : 317 pages
File Size : 55,5 Mb
Release : 2020-05-14
Category : Social Science
ISBN : 9780309671033

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Social Isolation and Loneliness in Older Adults by National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Health and Medicine Division,Board on Behavioral, Cognitive, and Sensory Sciences,Board on Health Sciences Policy,Committee on the Health and Medical Dimensions of Social Isolation and Loneliness in Older Adults Pdf

Social isolation and loneliness are serious yet underappreciated public health risks that affect a significant portion of the older adult population. Approximately one-quarter of community-dwelling Americans aged 65 and older are considered to be socially isolated, and a significant proportion of adults in the United States report feeling lonely. People who are 50 years of age or older are more likely to experience many of the risk factors that can cause or exacerbate social isolation or loneliness, such as living alone, the loss of family or friends, chronic illness, and sensory impairments. Over a life course, social isolation and loneliness may be episodic or chronic, depending upon an individual's circumstances and perceptions. A substantial body of evidence demonstrates that social isolation presents a major risk for premature mortality, comparable to other risk factors such as high blood pressure, smoking, or obesity. As older adults are particularly high-volume and high-frequency users of the health care system, there is an opportunity for health care professionals to identify, prevent, and mitigate the adverse health impacts of social isolation and loneliness in older adults. Social Isolation and Loneliness in Older Adults summarizes the evidence base and explores how social isolation and loneliness affect health and quality of life in adults aged 50 and older, particularly among low income, underserved, and vulnerable populations. This report makes recommendations specifically for clinical settings of health care to identify those who suffer the resultant negative health impacts of social isolation and loneliness and target interventions to improve their social conditions. Social Isolation and Loneliness in Older Adults considers clinical tools and methodologies, better education and training for the health care workforce, and dissemination and implementation that will be important for translating research into practice, especially as the evidence base for effective interventions continues to flourish.

Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 43,9 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864

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Modern Methods of Clinical Investigation by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Author : Ronda Hughes
Publisher : Department of Health and Human Services
Page : 592 pages
File Size : 55,6 Mb
Release : 2008
Category : Medical
ISBN : IOWA:31858055672798

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Patient Safety and Quality by Ronda Hughes Pdf

"Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043)." - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/

Author : Institute of Medicine,Food and Nutrition Board,Food Forum
Publisher : National Academies Press
Page : 192 pages
File Size : 51,7 Mb
Release : 2010-11-29
Category : Medical
ISBN : 9780309158831

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Providing Healthy and Safe Foods As We Age by Institute of Medicine,Food and Nutrition Board,Food Forum Pdf

Does a longer life mean a healthier life? The number of adults over 65 in the United States is growing, but many may not be aware that they are at greater risk from foodborne diseases and their nutritional needs change as they age. The IOM's Food Forum held a workshop October 29-30, 2009, to discuss food safety and nutrition concerns for older adults.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies
Publisher : National Academies Press
Page : 235 pages
File Size : 49,5 Mb
Release : 2018-03-01
Category : Medical
ISBN : 9780309468084

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Making Medicines Affordable by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies Pdf

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Author : National Research Council,Institute of Medicine,Board on Children, Youth, and Families,Committee on Improving the Health, Safety, and Well-Being of Young Adults
Publisher : National Academies Press
Page : 502 pages
File Size : 51,9 Mb
Release : 2015-01-27
Category : Medical
ISBN : 9780309309981

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Investing in the Health and Well-Being of Young Adults by National Research Council,Institute of Medicine,Board on Children, Youth, and Families,Committee on Improving the Health, Safety, and Well-Being of Young Adults Pdf

Young adulthood - ages approximately 18 to 26 - is a critical period of development with long-lasting implications for a person's economic security, health and well-being. Young adults are key contributors to the nation's workforce and military services and, since many are parents, to the healthy development of the next generation. Although 'millennials' have received attention in the popular media in recent years, young adults are too rarely treated as a distinct population in policy, programs, and research. Instead, they are often grouped with adolescents or, more often, with all adults. Currently, the nation is experiencing economic restructuring, widening inequality, a rapidly rising ratio of older adults, and an increasingly diverse population. The possible transformative effects of these features make focus on young adults especially important. A systematic approach to understanding and responding to the unique circumstances and needs of today's young adults can help to pave the way to a more productive and equitable tomorrow for young adults in particular and our society at large. Investing in The Health and Well-Being of Young Adults describes what is meant by the term young adulthood, who young adults are, what they are doing, and what they need. This study recommends actions that nonprofit programs and federal, state, and local agencies can take to help young adults make a successful transition from adolescence to adulthood. According to this report, young adults should be considered as a separate group from adolescents and older adults. Investing in The Health and Well-Being of Young Adults makes the case that increased efforts to improve high school and college graduate rates and education and workforce development systems that are more closely tied to high-demand economic sectors will help this age group achieve greater opportunity and success. The report also discusses the health status of young adults and makes recommendations to develop evidence-based practices for young adults for medical and behavioral health, including preventions. What happens during the young adult years has profound implications for the rest of the life course, and the stability and progress of society at large depends on how any cohort of young adults fares as a whole. Investing in The Health and Well-Being of Young Adults will provide a roadmap to improving outcomes for this age group as they transition from adolescence to adulthood.