Download or read book Research and Development in the Pharmaceutical Industry A CBO Study written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

Download or read book The Influence of the Pharmaceutical Industry written by Great Britain: Parliament: House of Commons: Health Committee and published by The Stationery Office. This book was released on 2005-04-26 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incorporating HC 1030-i to iii.

Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Download or read book Global Pharmaceuticals written by Adriana Petryna and published by Duke University Press. This book was released on 2006-03-15 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: DIVAnthropological study of the globalization of pharmaceuticals and its effects on local cultures, health, and economics./div

Download or read book Corporate Crime in the Pharmaceutical Industry Routledge Revivals written by John Braithwaite and published by Routledge. This book was released on 2013-10-08 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.

Download or read book Pharmaceuticals in the Environment written by R E Hester and published by Royal Society of Chemistry. This book was released on 2015-08-27 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicines play an important role in the treatment and prevention of disease in humans and animals, but residues from these medicines can be released into the environment through a number of routes during their manufacture, use and disposal. It is only recently that the potential environmental impacts of this exposure to pharmaceuticals are being considered. The book explores where pharmaceutical residues can be found, e.g. in surface waters, drinking water, sediments and the marine environment; the sources of these residues, from manufacture through to disposal of unused medicines; how these residues break down; and how this all impacts on wildlife and human health. In reviewing the current position and examining further possible impacts, this book is an important reference for researchers working in the pharmaceutical industry, as well as for environmentalists, policy makers and students on pharmacy and environmental science courses wanting to better understand the impacts of pharmaceuticals on the environment.

Download or read book Ethics and the Pharmaceutical Industry written by Michael A. Santoro and published by Cambridge University Press. This book was released on 2005-10-31 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Government officials and social critics have questioned whether the multibillion-dollar industry is fulfilling its social responsibilities. This doubt has been fueled by the national debate over drug pricing and affordable healthcare, and internationally by the battles against epidemic diseases, such as AIDS, in the developing world. Debates are raging over how the industry can and should be expected to act. The contributions in this book by leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, and marketing.

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

Download or read book The Trouble with Medical Journals written by Richard Smith and published by CRC Press. This book was released on 2024-11-01 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is a turbulent time for STM publishing. With moves towards open access to scientific literature, the future of medical journals is uncertain and unpredictable. This is the only book of its kind to address this problematic issue. Richard Smith, a previous editor of the British Medical Journal for twenty five years and one of the most influential people within medical journals and medicine depicts a compelling picture of medical publishing. Drawn from the author's own extensive and unrivalled experience in medical publishing, Smith provides a refreshingly honest analysis of current and future trends in journal publishing including peer review, ethics in medical publishing, the influence of the pharmaceutical industry as well as that of the mass media, and the risk that money can cloud objectivity in publishing. Full of personal anecdotes and amusing tales, this is a book for everyone, from researcher to patient, author to publisher and editor to reader. The controversial and highly topical nature of this book, will make uncomfortable reading for publishers, researchers, funding bodies and pharmaceutical companies alike making this useful resource for anyone with an interest in medicine or medical journals. Topic covered include: Libel and medical journals; Patients and medical journals; Medical journals and the mass media; Medical journals and pharmaceutical companies: uneasy bedfellows; Editorial independence; misconduct; and accountability; Ethical support and accountability for journals; Peer review: a flawed process and Conflicts of interest: how money clouds objectivity. This is a unique offering by the former BMJ editor- challenging, comprehensive and controversial. This must be the most controversial medical book of the 21st Century John Illman, MJA News Lively, full of anecdote and he [Smith] is brutally honest British Journal of Hospital Medicine ************************************************************************************************* Please note that the reference to Arup Banerjee on page 100 of this book should be to Anjan Banerjee. We apologise to Professor Arup Banerjee for this oversight. *************************************************************************************************

Download or read book Adverse Reactions written by Neil Pearce and published by Auckland University Press. This book was released on 2013-11-01 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recounting the fenoterol epidemic—a major medical controversy that took place more than 15 years ago—this narrative explores the involvement of the asthma drug that caused numerous asthma deaths. Although the epidemic occurred in New Zealand, its shocking discoveries and subsequent consequences attracted worldwide attention in medical journals and conferences. Neil Pearce, the researcher who discovered that fenoteral was the cause of the epidemic, tells this personal story while raising concerns about drug safety internationally and analyzing the battle between money and science in medical research.

Download or read book Pharmaceutical R D written by and published by DIANE Publishing. This book was released on 1993 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms.

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Deadly Medicines and Organised Crime written by Peter Gotzsche and published by CRC Press. This book was released on 2019-08-21 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the pharmaceutical industries and their charade of fraudulent behaviour, both in research and marketing where the morally repugnant disregard for human lives is the norm. He convincingly draws close co

Download or read book Hooked written by Howard Brody and published by Rowman & Littlefield. This book was released on 2007 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: For decades, medical professionals have betrayed the public's trust by accepting various benefits from the pharmaceutical industry. Both drug company representatives and doctors employ artful spin to portray this behavior positively to the public, and to themselves. In Hooked, Howard Brody argues that we can neither understand the problem, nor propose helpful solutions until we identify the many levels of activity connecting these purportedly noble industries. We can pass laws and enact regulations, but ultimately the medical profession must take responsibility for its own integrity. Hooked is a wake-up call for anyone expecting high quality, ethical medical care.