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Review Of The Fialuridine Fiau Clinical Trials
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Book Synopsis Review of the Fialuridine (FIAU) Clinical Trials by : Institute of Medicine
Download or read book Review of the Fialuridine (FIAU) Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 1995-03-14 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: In June 1993 a clinical trial of fialuridine (FIAU), a promising new medication for hepatitis B, was abruptly terminated when one of the 15 out-patients participating in the National Institutes of Health (NIH) study was suddenly hospitalized with liver failure. Although all the remaining patients were contacted and told to stop taking their medication, six more subsequently developed severe toxicity. Five patients died, and two others were probably saved from death only by having liver transplants. In response to a request from the Secretary of the Department of Health and Human Services, the IOM committee has analyzed the FIAU clinical trials, making recommendations for additional safeguards for the conduct of future clinical trials. This evaluation included the review of documents pertaining to investigational new drug submissions, protocols and consent forms from other clinical trials, as well as information available from other clinical and preclinical experience with compounds related to FIAU and its parent drug, fiacitibine (FIAC), which is metabolized to FIAU. The committee does not seek to affix responsibility for the adverse outcome of this NIH trial, but instead focuses on whether any rules or procedures governing the clinical trials process itself need to be changed, and if so, what burdens or costs such changes might place on future clinical trials.
Book Synopsis Mitochondrial Dysfunction Caused by Drugs and Environmental Toxicants by : Yvonne Will
Download or read book Mitochondrial Dysfunction Caused by Drugs and Environmental Toxicants written by Yvonne Will and published by John Wiley & Sons. This book was released on 2018-03-23 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developed as a one-stop reference source for drug safety and toxicology professionals, this book explains why mitochondrial failure is a crucial step in drug toxicity and how it can be avoided. • Covers both basic science and applied technology / methods • Allows readers to understand the basis of mitochondrial function, the preclinical assessments used, and what they reveal about drug effects • Contains both in vitro and in vivo methods for analysis, including practical screening approaches for drug discovery and development • Adds coverage about mitochondrial toxicity underlying organ injury, clinical reports on drug classes, and discussion of environmental toxicants affecting mitochondria
Author :Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials Publisher :National Academies Press ISBN 13 :0309573440 Total Pages :280 pages Book Rating :4.3/5 (95 download)
Book Synopsis Review of the Fialuridine (FIAU) Clinical Trials by : Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials
Download or read book Review of the Fialuridine (FIAU) Clinical Trials written by Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials and published by National Academies Press. This book was released on 1995-03-28 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: In June 1993 a clinical trial of fialuridine (FIAU), a promising new medication for hepatitis B, was abruptly terminated when one of the 15 out-patients participating in the National Institutes of Health (NIH) study was suddenly hospitalized with liver failure. Although all the remaining patients were contacted and told to stop taking their medication, six more subsequently developed severe toxicity. Five patients died, and two others were probably saved from death only by having liver transplants. In response to a request from the Secretary of the Department of Health and Human Services, the IOM committee has analyzed the FIAU clinical trials, making recommendations for additional safeguards for the conduct of future clinical trials. This evaluation included the review of documents pertaining to investigational new drug submissions, protocols and consent forms from other clinical trials, as well as information available from other clinical and preclinical experience with compounds related to FIAU and its parent drug, fiacitibine (FIAC), which is metabolized to FIAU. The committee does not seek to affix responsibility for the adverse outcome of this NIH trial, but instead focuses on whether any rules or procedures governing the clinical trials process itself need to be changed, and if so, what burdens or costs such changes might place on future clinical trials.
Download or read book Drug-Induced Liver Injury written by and published by Academic Press. This book was released on 2019-07-13 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. - Includes the authority and expertise of leading contributors in pharmacology - Presents the latest release in the Advances in Pharmacology series
Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin
Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
Book Synopsis The Unequal Burden of Cancer by : Institute of Medicine
Download or read book The Unequal Burden of Cancer written by Institute of Medicine and published by National Academies Press. This book was released on 1999-06-11 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: We know more about cancer prevention, detection, and treatment than ever beforeâ€"yet not all segments of the U.S. population have benefited to the fullest extent possible from these advances. Some ethnic minorities experience more cancer than the majority population, and poor peopleâ€"no matter what their ethnicityâ€"often lack access to adequate cancer care. This book provides an authoritative view of cancer as it is experienced by ethnic minorities and the medically underserved. It offers conclusions and recommendations in these areas: Defining and understanding special populations, and improving the collection of cancer-related data. Setting appropriate priorities for and increasing the effectiveness of specific National Institutes of Health (NIH) research programs, to ensure that special populations are represented in clinical trials. Disseminating research results to health professionals serving these populations, with sensitivity to the issues of cancer survivorship. The book provides background data on the nation's struggle against cancer, activities and expenditures of the NIH, and other relevant topics.
Book Synopsis Mann's Pharmacovigilance by : Elizabeth B. Andrews
Download or read book Mann's Pharmacovigilance written by Elizabeth B. Andrews and published by John Wiley & Sons. This book was released on 2014-03-24 with total page 878 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
Book Synopsis Contraceptive Research and Development by : Institute of Medicine
Download or read book Contraceptive Research and Development written by Institute of Medicine and published by National Academies Press. This book was released on 1996-11-04 with total page 534 pages. Available in PDF, EPUB and Kindle. Book excerpt: The "contraceptive revolution" of the 1960s and 1970s introduced totally new contraceptive options and launched an era of research and product development. Yet by the late 1980s, conditions had changed and improvements in contraceptive products, while very important in relation to improved oral contraceptives, IUDs, implants, and injectables, had become primarily incremental. Is it time for a second contraceptive revolution and how might it happen? Contraceptive Research and Development explores the frontiers of science where the contraceptives of the future are likely to be found and lays out criteria for deciding where to make the next R&D investments. The book comprehensively examines today's contraceptive needs, identifies "niches" in those needs that seem most readily translatable into market terms, and scrutinizes issues that shape the market: method side effects and contraceptive failure, the challenge of HIV/AIDS and other sexually transmitted diseases, and the implications of the "women's agenda." Contraceptive Research and Development analyzes the response of the pharmaceutical industry to current dynamics in regulation, liability, public opinion, and the economics of the health sector and offers an integrated set of recommendations for public- and private-sector action to meet a whole new generation of demand.
Book Synopsis Imaging Infections by : Sanjay K. Jain
Download or read book Imaging Infections written by Sanjay K. Jain and published by Springer. This book was released on 2017-05-25 with total page 263 pages. Available in PDF, EPUB and Kindle. Book excerpt: This books brings together multi-disciplinary expertise to provide comprehensive information about molecular imaging of infectious diseases. Also described are the development of new imaging technologies for infectious disease and their translation to the clinic. The overall goal of Imaging Infections: From Bench to Bedside is to spur interest and innovation in this emerging field. We anticipate that these technologies will not only allow unique insights into understanding pathogenesis of infections but also expedite bench-to-bedside translation of new therapeutics. While molecular imaging is already in common use in the clinic, this book demonstrates how it could also become a valuable tool for clinical studies, patient care, public health, and for enabling precision medicine for infectious diseases.
Author :Joseph M. Colacino Publisher :Springer Science & Business Media ISBN 13 :9783764359560 Total Pages :262 pages Book Rating :4.3/5 (595 download)
Book Synopsis Hepatitis Prevention and Treatment by : Joseph M. Colacino
Download or read book Hepatitis Prevention and Treatment written by Joseph M. Colacino and published by Springer Science & Business Media. This book was released on 2004-10-25 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chronic viral hepatitis has emerged as one of the most common causes of disease and death worldwide. Because of their unique modes of replication and intimate association with the host immune system, hepatitis B virus (HBV) and hepatitis C virus (HCV) pose challenging problems to scientists in basic and applied research as well as to clinicians engaged in disease management. Although approved antiviral therapy is available for chronic HBV, the emergence of viral resistance provides a rationale for the development of novel chemotherapeutic agents. The lack of a robust cell culture system for HCV replication and a readily accessible small-animal model of HCV infection have hampered the development of antiviral agents for HCV. Neverthe-less, new antiviral agents targeting HCV are now in preclinical and clinical development. This monograph, providing an up-to-date overview of the field of Hepatitis Prevention and Treatment, includes contributions from internationally recognized experts in the field of viral hepatitis, and covers the current state of knowledge and practice regarding the molecular biology, immunology, biochemistry, pharmacology and clinical aspects of chronic HBV and HCV infection. The volume includes salient topics such as: the history and epidemiology of HBV and HCV; recent insights into the molecular mechanisms of viral replication; the host immune response to infection and a discussion of the use (HBV) or potential development (HCV) of vaccines; the current standard of care for chronically-infected patients; and emerging therapies and issues associated with current antiviral treatments. The latest information to researchers and clinicians actively engaged in viral hepatitis research is provided, but also sufficient background and discussion of the literature to benefit the newcomer to the field.
Download or read book Rigor Mortis written by Richard Harris and published by Hachette UK. This book was released on 2017-04-04 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential book to understanding whether the new miracle cure is good science or simply too good to be true American taxpayers spend $30 billion annually funding biomedical research, but over half of these studies can't be replicated due to poor experimental design, improper methods, and sloppy statistics. Bad science doesn't just hold back medical progress, it can sign the equivalent of a death sentence for terminal patients. In Rigor Mortis, Richard Harris explores these urgent issues with vivid anecdotes, personal stories, and interviews with the top biomedical researchers. We need to fix our dysfunctional biomedical system -- before it's too late.
Book Synopsis Liver Disease in Children by : Frederick J. Suchy
Download or read book Liver Disease in Children written by Frederick J. Suchy and published by Cambridge University Press. This book was released on 2007-05-07 with total page 995 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised new edition of the premier reference on pediatric liver disease. Liver Disease in Children, 3rd Edition provides authoritative coverage of every aspect of liver disease affecting infants, children, and adolescents. The book offers an integrated approach to the science and clinical practice of pediatric hepatology and charts the substantial progress in understanding and treating these diseases. Chapters are written by international experts and address the unique pathophysiology, manifestations, and management of these disorders in the pediatric population. The third edition has been thoroughly updated and features new contributions on liver development, cholestatic and autoimmune disorders, fatty liver disease, and inborn errors of metabolism. With the continued evolution of pediatric hepatology as a discipline, this text remains an essential reference for all physicians involved in the care of children with liver disease.
Book Synopsis Orphans and Incentives by : Institute of Medicine
Download or read book Orphans and Incentives written by Institute of Medicine and published by National Academies Press. This book was released on 1997-10-30 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infectious diseases remain a leading cause of prolonged illness, premature mortality, and soaring health costs. In the United States in 1995, infectious diseases were the third leading cause of death, right behind heart disease and cancer. Mortality is mounting over time, owing to HIV/AIDS, pneumonia, and septicemia, with drug resistance playing an ever-increasing role in each of these disease categories. This book, a report from a Forum on Emerging Infections workshop, focuses on product areas where returns from the market might be perceived as being too small or too complicated by other factors to compete in industrial portfolios with other demands for investment. Vaccines are quintessential examples of such products. The lessons learned fall into four areas, including what makes intersectoral collaboration a reality, the notion of a product life cycle, the implications of divergent sectoral mandates and concepts of risk, and the roles of advocacy and public education. The summary contains an examination of the Children's Vaccine Initiative and other models, an industry perspective on the emerging infections agenda, and legal and regulatory issues.
Book Synopsis Principles of Genome Analysis and Genomics by : Sandy B. Primrose
Download or read book Principles of Genome Analysis and Genomics written by Sandy B. Primrose and published by John Wiley & Sons. This book was released on 2009-04-01 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the first draft of the human genome project in the publicdomain and full analyses of model genomes now available, thesubject matter of 'Principles of Genome Analysis and Genomics' iseven 'hotter' now than when the first two editions were publishedin 1995 and 1998. In the new edition of this very practical guideto the different techniques and theory behind genomes and genomeanalysis, Sandy Primrose and new author Richard Twyman provide afresh look at this topic. In the light of recent excitingadvancements in the field, the authors have completely revised andrewritten many parts of the new edition with the addition of fivenew chapters. Aimed at upper level students, it is essential thatin this extremely fast moving topic area the text is up to date andrelevant. Completely revised new edition of an establishedtextbook. Features new chapters and examples from exciting new researchin genomics, including the human genome project. Excellent new co-author in Richard Twyman, also co-author ofthe new edition of hugely popular Principles of GeneManipulation. Accompanying web-page to help students deal with this difficulttopic at www.blackwellpublishing.com/primrose
Book Synopsis Evaluation and Treatment of Myopathies by : Robert Griggs
Download or read book Evaluation and Treatment of Myopathies written by Robert Griggs and published by Contemporary Neurology. This book was released on 2014 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preceded by Evaluation and treatment of myopathies / Robert C. Griggs, Jerry R. Mendell, Robert G. Miller. c1995.
Book Synopsis The Trials of Socrates by : C. D. C. Reeve
Download or read book The Trials of Socrates written by C. D. C. Reeve and published by Hackett Publishing. This book was released on 2002-01-01 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique and expertly annotated collection of the classic accounts of Socrates left by Plato, Aristophanes, and Xenophon features new translations of Euthyphro, Apology, Crito, and the death scene from Phaedo by C. D. C. Reeve, Peter Meineck's translation of Clouds, and James Doyle's translation of Apology of Socrates.
Book Synopsis Hepatotoxicity by : Hyman J. Zimmerman
Download or read book Hepatotoxicity written by Hyman J. Zimmerman and published by Lippincott Williams & Wilkins. This book was released on 1999 with total page 850 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by the foremost authority in the field, this volume is a comprehensive review of the multifaceted phenomenon of hepatotoxicity. Dr. Zimmerman examines the interface between chemicals and the liver; the latest research in experimental hepatotoxicology; the hepatotoxic risks of household, industrial, and environmental chemicals; and the adverse effects of drugs on the liver. This thoroughly revised, updated Second Edition features a greatly expanded section on the wide variety of drugs that can cause liver injury. For quick reference, an appendix lists these medications and their associated hepatic injuries. Also included are in-depth discussions of drug metabolism and factors affecting susceptibility to liver injury.