Review Of The Fialuridine Fiau Clinical Trials PDF Download
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| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 279 |
| Release | : 1995-03-14 |
| Genre | : Medical |
| ISBN | : 0309176611 |
Download Review of the Fialuridine (FIAU) Clinical Trials Book in PDF, ePub and Kindle
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 280 |
| Release | : 1995-04-14 |
| Genre | : Medical |
| ISBN | : 0309052793 |
Download Review of the Fialuridine (FIAU) Clinical Trials Book in PDF, ePub and Kindle
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.
| Author | : Swartz M Manning FJ (editors) |
| Publisher | : |
| Total Pages | : |
| Release | : 1995 |
| Genre | : Clinical trials |
| ISBN | : |
Download Review of the Fialuridine (FIAU) Clinical Trials Book in PDF, ePub and Kindle
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 187 |
| Release | : 2016-06-01 |
| Genre | : Medical |
| ISBN | : 0309438020 |
Download Eliminating the Public Health Problem of Hepatitis B and C in the United States Book in PDF, ePub and Kindle
Hepatitis B and C cause most cases of hepatitis in the United States and the world. The two diseases account for about a million deaths a year and 78 percent of world's hepatocellular carcinoma and more than half of all fatal cirrhosis. In 2013 viral hepatitis, of which hepatitis B virus (HBV) and hepatitis C virus (HCV) are the most common types, surpassed HIV and AIDS to become the seventh leading cause of death worldwide. The world now has the tools to prevent hepatitis B and cure hepatitis C. Perfect vaccination could eradicate HBV, but it would take two generations at least. In the meantime, there is no cure for the millions of people already infected. Conversely, there is no vaccine for HCV, but new direct-acting antivirals can cure 95 percent of chronic infections, though these drugs are unlikely to reach all chronically-infected people anytime soon. This report, the first of two, examines the feasibility of hepatitis B and C elimination in the United States and identifies critical success factors. The phase two report will outline a strategy for meeting the elimination goals discussed in this report.
| Author | : Yvonne Will |
| Publisher | : John Wiley & Sons |
| Total Pages | : 816 |
| Release | : 2018-03-23 |
| Genre | : Science |
| ISBN | : 1119329744 |
Download Mitochondrial Dysfunction Caused by Drugs and Environmental Toxicants Book in PDF, ePub and Kindle
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 | : |
| Publisher | : Academic Press |
| Total Pages | : 288 |
| Release | : 2019-07-13 |
| Genre | : Medical |
| ISBN | : 0128173173 |
Download Drug-Induced Liver Injury Book in PDF, ePub and Kindle
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
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 352 |
| Release | : 1999-05-11 |
| Genre | : Medical |
| ISBN | : 030917337X |
Download The Unequal Burden of Cancer Book in PDF, ePub and Kindle
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.
| Author | : John I. Gallin |
| Publisher | : Elsevier |
| Total Pages | : 447 |
| Release | : 2011-04-28 |
| Genre | : Science |
| ISBN | : 0080489567 |
Download Principles and Practice of Clinical Research Book in PDF, ePub and Kindle
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
| Author | : Elizabeth B. Andrews |
| Publisher | : John Wiley & Sons |
| Total Pages | : 878 |
| Release | : 2014-03-24 |
| Genre | : Medical |
| ISBN | : 1118820142 |
Download Mann's Pharmacovigilance Book in PDF, ePub and Kindle
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.
| Author | : Sanjay K. Jain |
| Publisher | : Springer |
| Total Pages | : 261 |
| Release | : 2017-05-25 |
| Genre | : Medical |
| ISBN | : 3319545922 |
Download Imaging Infections Book in PDF, ePub and Kindle
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.
