Download or read book Drug Safety written by United States. General Accounting Office and published by . This book was released on 2001 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Impact of Global Drug Policy on Women written by Julia Buxton and published by Emerald Group Publishing. This book was released on 2020-11-19 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ebook edition of this title is Open Access and freely available to read online. Examining the impact of drug criminalisation on a previously overlooked demographic, this book argues that women are disproportionately affected by a flawed policy approach.
Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Women and Health Research written by Anna C. Mastroianni and published by . This book was released on 1994 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Invisible Women written by Caroline Criado Perez and published by Abrams. This book was released on 2019-03-12 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: The landmark, prize-winning, international bestselling examination of how a gender gap in data perpetuates bias and disadvantages women. #1 International Bestseller * Winner of the Financial Times and McKinsey Business Book of the Year Award * Winner of the Royal Society Science Book Prize Data is fundamental to the modern world. From economic development to health care to education and public policy, we rely on numbers to allocate resources and make crucial decisions. But because so much data fails to take into account gender, because it treats men as the default and women as atypical, bias and discrimination are baked into our systems. And women pay tremendous costs for this insidious bias: in time, in money, and often with their lives. Celebrated feminist advocate Caroline Criado Perez investigates this shocking root cause of gender inequality in Invisible Women. Examining the home, the workplace, the public square, the doctor’s office, and more, Criado Perez unearths a dangerous pattern in data and its consequences on women’s lives. Product designers use a “one-size-fits-all” approach to everything from pianos to cell phones to voice recognition software, when in fact this approach is designed to fit men. Cities prioritize men’s needs when designing public transportation, roads, and even snow removal, neglecting to consider women’s safety or unique responsibilities and travel patterns. And in medical research, women have largely been excluded from studies and textbooks, leaving them chronically misunderstood, mistreated, and misdiagnosed. Built on hundreds of studies in the United States, in the United Kingdom, and around the world, and written with energy, wit, and sparkling intelligence, this is a groundbreaking, highly readable exposé that will change the way you look at the world.
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Download or read book Research on Women s Health written by and published by . This book was released on 1997 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drugs for Pregnant and Lactating Women E Book written by Carl P. Weiner and published by Elsevier Health Sciences. This book was released on 2018-10-17 with total page 1300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Logically organized and easy to use, Drugs for Pregnant and Lactating Women, 3rd Edition, is your #1 resource for details on how virtually all of today’s drugs and herbal supplements interact with pregnancy and lactation. More than just a dosing manual, this unique title by Dr. Carl P. Weiner fully explains whether each drug is FDA-approved for use by expecting or nursing mothers, is known to be safe for use, or is known to pose a danger. With up-to-date coverage of nearly 2,000 substances, it provides the thorough details you need to choose the most effective course of treatment. Uses a consistent, easy-to-follow format for each substance: generic and trade name • class • indications • mechanism of action • dosage, with contraindications and cautions • maternal considerations • fetal considerations • drug interactions • breastfeeding safety • references • and summary information. Describes over-the-counter drugs and alternative medications as well as prescription drugs. Uses an eye-catching icon to highlight known teratogens. Includes international drug names to give this reference a global perspective. Features new letter thumb tabs for easier navigation. Includes dozens of new drugs and thorough updates throughout.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Her 2 written by Robert Bazell and published by Random House. This book was released on 2011-04-27 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Two years after she underwent a mastectomy and chemotherapy, Barbara Bradfield's aggressive breast cancer had recurred and spread to her lungs. The outlook was grim. Then she took part in Genentech's clinical trials for a new drug. Five years later she remains cancer-free. Her-2 is the biography of Herceptin, the drug that provoked dramatic responses in Barbara Bradfield and other women in the trials and that offers promise for hundreds of thousands of breast cancer patients. Unlike chemotherapy or radiation, Herceptin has no disabling side effects. It works by inactivating Her-2/neu--a protein that makes cancer cells grow especially quickly-- produced by a gene found in 25 to 30 percent of all breast tumors. Herceptin caused some patients' cancers to disappear completely; in others, it slowed the progression of the disease and gave the women months or years they wouldn't otherwise have had. Herceptin is the first treatment targeted at a gene defect that gives rise to cancer. It marks the beginning of a new era of treatment for all kinds of cancers. Robert Bazell presents a riveting account of how Herceptin was born. Her-2 is a story of dramatic discoveries and strong personalities, showing the combination of scientific investigation, money, politics, ego, corporate decisions, patient activism, and luck involved in moving this groundbreaking drug from the lab to a patient's bedside. Bazell's deft portraits introduce us to the remarkable people instrumental in Herceptin's history, including Dr. Dennis Slamon, the driven UCLA oncologist who played the primary role in developing the treatment; Lily Tartikoff, wife of television executive Brandon Tartikoff, who tapped into Hollywood money and glamour to help fund Slamon's research; and Marti Nelson, who inspired the activists who lobbied for a "compassionate use" program that would allow women outside the clinical trials to have access to the limited supplies of Herceptin prior to FDA approval of the drug. And throughout there are the stories of the heroic women with advanced breast cancer who volunteered for the trials, risking what time they had left on an unproven treatment. Meticulously researched, written with clarity and compassion, Her-2 is masterly reporting on cutting-edge science.
Download or read book Principles and Practice of Pharmaceutical Medicine written by Lionel D. Edwards and published by John Wiley & Sons. This book was released on 2007-04-30 with total page 780 pages. Available in PDF, EPUB and Kindle. Book excerpt: The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS
Download or read book The Drug Development Paradigm in Oncology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-02-12 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Drug Truths written by John L. LaMattina and published by John Wiley & Sons. This book was released on 2012-03-02 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book answers the questions about the process and costs of pharmaceutical R & D in a compelling narrative focused on the discovery and development of important new medicines. It gives an insider's account of the pharmaceutical industry drug discovery process, the very real costs of misperceptions about the industry, the high stakes--both economic and scientific--of developing drugs, the triumphs that come when new compounds reach the market and save lives, and the despair that follows when new compounds fail. In the book, John LaMattina, former president of Pfizer Global Research and Development, weaves themes critical to a vital drug discovery environment in the context. This is a story that Dr. LaMattina is uniquely qualified to tell.
Download or read book The Turnaway Study written by Diana Greene Foster and published by Simon and Schuster. This book was released on 2021-06 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Now with a new afterword by the author"--Back cover.
Download or read book The Governance of Female Drug Users written by Du Rose, Natasha and published by Policy Press. This book was released on 2016-06-01 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: Available Open Access under CC-BY-NC licence. This book is the first to examine how female drug user's identities, and hence their experiences, are shaped by drug policies. It analyses how the subjectivities ascribed to women users within drug policy sustain them in their problematic use and reinforce their social exclusion. Challenging popular misconceptions of female users, the book calls for the formulation of drug policies to be based on gender equity and social justice. It will appeal to academics in the social sciences, practitioners and policy makers.
