Expanding Access To Investigational Therapies For Hiv Infection And Aids

Author : Institute of Medicine,Roundtable for the Development of Drugs and Vaccines Against AIDS
Publisher : National Academies Press
Page : 84 pages
File Size : 44,6 Mb
Release : 1991-02-01
Category : Medical
ISBN : 9780309044905

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Expanding Access to Investigational Therapies for HIV Infection and AIDS by Institute of Medicine,Roundtable for the Development of Drugs and Vaccines Against AIDS Pdf

The call for a "parallel track" for AIDS drug developmentâ€"a proposal that would allow the early distribution of AIDS drugs to large numbers of patients in parallel with the conventional clinical trials that assess the drugs' safety and efficacyâ€"has sparked controversy within the scientific community. Questions have arisen about the risks to patients of such a plan, about its potential effect on the successful completion of standard controlled trials, and about whether the parallel track will generate useful data. Larger questions have also been raised about whether the parallel track heralds fundamental changes in the philosophy underlying drug regulation in the United States, about the costs and financing of investigational therapies and associated medical costs, and about the role of expanded access mechanisms for drugs in reaching those whose health care is generally inadequate. This volume summarizes a conference hosted by the Institute of Medicine that illuminated these issues.

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Commission on Behavioral and Social Sciences and Education,Panel on Monitoring the Social Impact of the AIDS Epidemic
Publisher : National Academies Press
Page : 337 pages
File Size : 48,7 Mb
Release : 1993-02-01
Category : Medical
ISBN : 9780309046282

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The Social Impact of AIDS in the United States by National Research Council,Division of Behavioral and Social Sciences and Education,Commission on Behavioral and Social Sciences and Education,Panel on Monitoring the Social Impact of the AIDS Epidemic Pdf

Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.

Author : Anonim
Publisher : Unknown
Page : 184 pages
File Size : 49,9 Mb
Release : 1995-06
Category : AIDS (Disease)
ISBN : PURD:32754082152582

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AIDS Bibliography by Anonim Pdf

Author : World Health Organization
Publisher : Unknown
Page : 429 pages
File Size : 50,5 Mb
Release : 2016
Category : AIDS (Disease)
ISBN : 9241549688

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Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection by World Health Organization Pdf

These guidelines provide guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. They are structured along the continuum of HIV testing, prevention, treatment and care. This edition updates the 2013 consolidated guidelines on the use of antiretroviral drugs following an extensive review of evidence and consultations in mid-2015, shared at the end of 2015, and now published in full in 2016. It is being published in a changing global context for HIV and for health more broadly.

Author : Anonim
Publisher : World Bank Publications
Page : 270 pages
File Size : 50,5 Mb
Release : 2006-01-01
Category : Medical
ISBN : 9780821367568

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The Economics of Effective AIDS Treatment by Anonim Pdf

HIV is the leading cause of premature death in Thailand. Since the first case of AIDS was reported in 1984 more than one million Thais have been infected. The social, human and economic costs of this burden are enormous. The Thai government has shown a strong commitment to providing care and support to persons living with HIV/AIDS by launching the National Access to Care Program (NAPHA) in 2003, which provides for publicly financed antiretroviral therapy (ART) to all HIV-infected people. This book documents through interviews how ART has radically changed the lives of those living with HIV. In the words of an HIV positive 29-year old man, ART is a "miracle." The book then develops an innovative analytical framework and uses it to show how the future sustainability and cost-effectiveness of this ambitious program depend critically on Thai government choices of AIDS treatment policy, HIV prevention policy and AIDS drug pricing. For the most likely assumptions, the book estimates that ART will save years of healthy life at a cost of between $700 and $2,400 per year. Successful AIDS treatment accumulates ever-increasing numbers of patients who need subsidized ART. Despite the magnitude of the resulting fiscal burden, the authors judge this expenditure to be a worthwhile public health investment for Thailand, However, they show that the future sustainability of the program will hinge critically on how well the government manages the quality of ART service delivery, on whether it is able to sustain its past successes in HIV prevention and on its negotiations with multinational pharmaceutical manufacturers on the prices of new AIDS drugs.

Author : William David Hardy
Publisher : Oxford University Press
Page : 617 pages
File Size : 55,7 Mb
Release : 2017-04-18
Category : AIDS (Disease)
ISBN : 9780190493097

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Fundamentals of HIV Medicine by William David Hardy Pdf

Completely updated for 2017, Fundamentals of HIV Medicine is a comprehensive clinical care publication for the treatment of HIV/AIDS. Published by the American Academy of HIV Medicine, the book offers physicians, pharmacists, nurse practitioners, and other care providers the most up-to-date overview of the latest HIV treatments and guidelines plus online access to CME. The online access expires August 2018. Embodying the AAHIVM's commitment to promoting uniform excellence in care of seropositive patients, Fundamentals of HIV Medicine 2017 empowers health professionals to deliver standardized, life-sustaining treatment to the patients who need it most. It will serve as an essential clinical reference and provide valuable career enrichment to users across the spectrum of HIV care, treatment, and prevention.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum
Publisher : National Academies Press
Page : 145 pages
File Size : 53,8 Mb
Release : 2018-02-12
Category : Medical
ISBN : 9780309457972

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The Drug Development Paradigm in Oncology by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum Pdf

Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

Author : Mikkael A. Sekeres
Publisher : MIT Press
Page : 319 pages
File Size : 41,9 Mb
Release : 2024-02-06
Category : Medical
ISBN : 9780262548397

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Drugs and the FDA by Mikkael A. Sekeres Pdf

How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer’s drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug’s safety and efficacy? In Drugs and the FDA, Mikkael Sekeres—a leading oncologist and former chair of the FDA’s cancer drug advisory committee—tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA’s evolution, demonstrating how its system of checks and balances works—or doesn’t work.

Author : Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner
Publisher : John Wiley & Sons
Page : 820 pages
File Size : 51,6 Mb
Release : 2022-09-07
Category : Medical
ISBN : 9781119574187

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Integrated Pharmaceutics by Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner Pdf

This work is an examination of all aspects of the science in developing effective dosage form for drug delivery Pharmaceutics refers to the subfield of pharmaceutical sciences that develops drug delivery products or devices to optimize the drug's performance once administered. This multidisciplinary field draws on physical chemistry, organic chemistry, and biophysics to generate and refine these crucial elements of medical care. Moreover, incorporating such disparate dimensions of drug product design as material properties and legal regulation bridges the gap between effective chemicals and viable medical treatments. Integrated Pharmaceutics provides a comprehensive introduction to the creation and manufacture of effective dosage forms for drug delivery. It presents its subject following the principles of physical pharmacy, product design, and drug regulations. This tripartite structure allows readers to move from theory to practice, beginning from a firm foundation of physical pharmacy principles, including drug solubility and stability estimation, rheology, and interfacial properties. From there, it proceeds to discussions of drug product design and of harmonizing pharmaceutical design with the regulatory regimens and technological standards of the United States, European Union, and Japan. Readers of the second edition of Integrated Pharmaceutics will also find: A glossary defining key terms, extensive informative appendices, and a list of references leading to the primary literature in the field for each chapter Earlier chapters are expanded, with additional new chapters including one entitled “Biotechnology Products” Supplementary instructor guide with questions and solutions available online for registered professors Updated regulatory guidelines including quality by design, design space analysis, process analytical technology, polymorphism characterization, blend sample uniformity, and stability protocols Integrated Pharmaceutics is a useful textbook for graduate students in pharmaceutical sciences, drug formulation and design, and biomedical engineering. In addition, professionals in the pharmaceutical industry, including regulatory bodies, will find it a helpful reference guide.

Author : John G. Francis,Leslie P. Francis
Publisher : Springer Nature
Page : 224 pages
File Size : 41,5 Mb
Release : 2021-03-17
Category : Philosophy
ISBN : 9783030639280

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Sustaining Surveillance: The Importance of Information for Public Health by John G. Francis,Leslie P. Francis Pdf

This book presents a comprehensive theory of the ethics and political philosophy of public health surveillance based on reciprocal obligations among surveillers, those under surveillance, and others potentially affected by surveillance practices. Public health surveillance aims to identify emerging health trends, population health trends, treatment efficacy, and methods of health promotion--all apparently laudatory goals. Nonetheless, as with anti-terrorism surveillance, public health surveillance raises complex questions about privacy, political liberty, and justice both of and in data use. Individuals and groups can be chilled in their personal lives, stigmatized or threatened, and used for the benefit of others when health information is wrongfully collected or used. Transparency and openness about data use, public involvement in decisions, and just distribution of the benefits of surveillance are core elements in the justification of surveillance practices. Understanding health surveillance practices, the concerns it raises, and how to respond to them is critical not only to ethical and trustworthy but also to publicly acceptable and ultimately sustainable surveillance practices. The book is of interest to scholars and practitioners of the ethics and politics of public health, bioethics, privacy and data technology, and health policy. These issues are ever more pressing in pandemic times, where misinformation can travel quickly and suspicions about disease spread, treatment efficacy, and vaccine safety can have devastating public health effects.

Author : Frank M. McClellan
Publisher : Rutgers University Press
Page : 203 pages
File Size : 45,5 Mb
Release : 2019-12-13
Category : Law
ISBN : 9781978802971

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Healthcare and Human Dignity by Frank M. McClellan Pdf

The individual and structural biases that affect the American healthcare system have serious emotional and physical consequences that all too often go unseen. These biases are often rooted in power, class, racial, gender or sexual orientation prejudices, and as a result, the injured parties usually lack the resources needed to protect themselves. In Healthcare and Human Dignity, individual worth, equality, and autonomy emerge as the dominant values at stake in encounters with doctors, nurses, hospitals, and drug companies. Although the public is aware of legal battles over autonomy and dignity in the context of death, the everyday patient’s need for dignity has received scant attention. Thus, in Healthcare, law professor Frank McClellan’s collection of cases and individual experiences bring these stories to life and establish beyond doubt that human dignity is of utmost priority in the everyday process of healthcare decision making.

Author : W. David Hardy
Publisher : Oxford University Press
Page : 128 pages
File Size : 43,6 Mb
Release : 2021-06-08
Category : Medical
ISBN : 9780197576656

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Fundamentals of HIV Medicine 2021 by W. David Hardy Pdf

The essential work in HIV for providers and pharmacists, updated for 2021. Includes CME access code for 2021 AAHIVS, AAHIVP, or AAHIVE study materials and accreditation! An end-to-end clinical resource for the treatment of individuals with HIV/AIDS, Fundamentals of HIV Medicine has served as a key resource for clinicians preventing and treating HIV for over a decade. Now updated for 2021, Fundamentals of HIV Medicine 2021 offers state-of-the-art continuing education for physicians, pharmacists, nurse practitioners, nurses, and other professionals working in the care of HIV patients. With this volume, practitioners will have immediate, indexed access to the most updated science, research, and guidelines related to all aspects of HIV care and prevention. This revised edition features key clinical updates across classic domains of HIV medicine along with recent research in HIV medicine including HIV workforce strains and PrEP, newly emerging antiretroviral treatment options, and the evolving effects of COVID-19 on HIV care. Embodying the American Academy of HIV Medicine's commitment to excellence in the care of seropositive patients, Fundamentals of HIV Medicine 2021 is a must-have for health professionals across HIV care, treatment, and prevention. Note: This edition includes a login for online CME questions and accreditation

Author : Anonim
Publisher : Unknown
Page : 214 pages
File Size : 49,5 Mb
Release : 1991
Category : Medicine, Preventive
ISBN : UCBK:C050001633

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Prevention by Anonim Pdf

Author : United States. Office of Disease Prevention and Health Promotion
Publisher : Unknown
Page : 212 pages
File Size : 45,6 Mb
Release : 1992
Category : Health planning
ISBN : MINN:31951D00875817R

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Prevention '91/'92 by United States. Office of Disease Prevention and Health Promotion Pdf

Author : Anonim
Publisher : Office of Technology Assessment
Page : 212 pages
File Size : 43,7 Mb
Release : 1995
Category : Medical
ISBN : MINN:31951D01230317M

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Adverse Reactions to HIV Vaccines by Anonim Pdf