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Generic Drug Substitution
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Book Synopsis Report of the Select Joint Committee on Generic Drug Substitution by : Select Joint Committee on Generic Drug Substitution
Download or read book Report of the Select Joint Committee on Generic Drug Substitution written by Select Joint Committee on Generic Drug Substitution and published by . This book was released on 1978 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Generic Drug Substitution by : Calvin Azama
Download or read book Generic Drug Substitution written by Calvin Azama and published by . This book was released on 1979 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Generic Substitution and Prescription Drug Prices by : Alison Masson
Download or read book Generic Substitution and Prescription Drug Prices written by Alison Masson and published by . This book was released on 1985 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309468086 Total Pages :235 pages Book Rating :4.3/5 (94 download)
Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Download or read book Generic written by Jeremy A. Greene and published by JHU Press. This book was released on 2014-10-27 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: The turbulent history of generic pharmaceuticals raises powerful questions about similarity and difference in modern medicine. Generic drugs are now familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals in this gripping narrative, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter. How do we know what parts of a pill really matter? Decisions about which differences are significant and which are trivial in the world of therapeutics are not resolved by simple chemical or biological assays alone. As Greene reveals in this fascinating account, questions of therapeutic similarity and difference are also always questions of pharmacology and physiology, of economics and politics, of morality and belief. Generic is the first book to chronicle the social, political, and cultural history of generic drugs in America. It narrates the evolution of the generic drug industry from a set of mid-twentieth-century "schlock houses" and "counterfeiters" into an agile and surprisingly powerful set of multinational corporations in the early twenty-first century. The substitution of bioequivalent generic drugs for more expensive brand-name products is a rare success story in a field of failed attempts to deliver equivalent value in health care for a lower price. Greene’s history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.
Book Synopsis Generic Drug Substitution by : Keith H. Fukumoto
Download or read book Generic Drug Substitution written by Keith H. Fukumoto and published by . This book was released on 1990 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Approved Prescription Drug Products with Therapeutic Equivalence Evaluations by :
Download or read book Approved Prescription Drug Products with Therapeutic Equivalence Evaluations written by and published by . This book was released on 1984 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
Book Synopsis How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry by :
Download or read book How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry written by and published by U.S. Government Printing Office. This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Generic Drug Product Development by : Isadore Kanfer
Download or read book Generic Drug Product Development written by Isadore Kanfer and published by CRC Press. This book was released on 2016-04-19 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica
Book Synopsis The Dose Makes the Poison by : M. Alice Ottoboni
Download or read book The Dose Makes the Poison written by M. Alice Ottoboni and published by Wiley. This book was released on 1997-05-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Dose Makes the Poison A Plain-Language Guide to Toxicology Second Edition M. Alice Ottoboni Increasing media coverage of reports on the effects of chemicals, new recognition within government and industry of the need to protect against exposure, and other current issues are elevating the public's concern about the health effects of synthetic chemicals in our environment. Unfortunately, much of this concern is based more on sensational news reports and half-truths than on scientific facts. This second edition of a widely read and highly acclaimed work reviews and explains the facts of chemical dangers in a clear and understandable manner. It objectively discusses the factors determining whether chemicals in our air, food, and water are harmful or harmless, and puts the dose - response relationship of chemicals in proper perspective. Effects of chemicals encountered at home and at work are presented in layman's language to assure understanding without having to turn to other references. Thoughtful discussions of controversial issues help you to understand news media reports on toxicology, avoid the half-truths that lead to "poison paranoia," and make informed judgments about our use and control of chemicals. Extensively revised, the second edition is also reorganized to expedite access to specific information. All experimental and analytical methods are in one section, and references to the origins of toxicology and regulation of chemicals are in another separate section to improve ease of reading. In addition, coverage of subjects such as public distrust of science, epidemiology, reproductive toxicology, and risk have been expanded to provide a better understanding of the relationship of toxicology to current environmental problems. All aspects of exposure and its effects are reviewed, including * How chemicals cause harm--toxicity, sensitization, corrosiveness, irritation, radioactivity, and other properties * Routes of exposure--skin, inhalation, oral, and combinations * Factors that influence degree of toxicity--species, age, sex, nutrition, state of health, presence of other chemicals, adaptation, and possibly, light * Chemicals that cause cancer and birth defects Chapters on toxicity of chemicals address no-effect levels and thresholds, margins of safety, and bioaccumulation. You'll see how the effects of chemicals are studied and how health problems are traced to environmental causes. Also clarified are differences between actual risk and perceived risk of various chemicals. With the media presenting us daily with new findings on chemical risks, this book provides a welcome "antidote" to the confusion. The Dose Makes the Poison is an easy-to-read review of toxicology that has become "required reading" for scientists and managers throughout industry; public health officials; environmental scientists; industrial hygienists; hazardous waste workers ; and anyone who wishes to improve his or her understanding of toxic chemicals without taking the time to go back to school.
Author :United States. Federal Trade Commission. Bureau of Consumer Protection Publisher : ISBN 13 : Total Pages :390 pages Book Rating :4.3/5 (91 download)
Book Synopsis Drug Product Selection by : United States. Federal Trade Commission. Bureau of Consumer Protection
Download or read book Drug Product Selection written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1979 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis EBOOK: Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality by : Elias Mossialos
Download or read book EBOOK: Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality written by Elias Mossialos and published by McGraw-Hill Education (UK). This book was released on 2004-06-16 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This thoughtful and comprehensive book represents the best work I have seen on the current situation concerning medication policies in the EU. It is not just that this is a very up-to-date compendium of facts and data across a wide variety of domains that impact on pharmaceutical regulation. The book is also strong on analysis of those facts as well." Jerry Avorn, Harvard Medical School. "This book offers a comprehensive examination of approaches to manage pharmaceutical expenditures in Europe. It is a must-read for those who seek to understand and navigate the changing regulatory environment for medicines in the European Union." Bernie O'Brien, McMaster University, Canada. The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of pharmaceutical regulation, this book examines approaches used to manage pharmaceutical expenditure across Europe and what impact these strategies have had on efficiency, quality, equity and cost of pharmaceutical care.Regulating Pharmaceuticals in Europe is an important book for students of health policy, regulation and management, and for health managers and policy makers. The editors: Elias Mossialos is Brian Abel-Smith Professor of Health Policy at the London School of Economics and Political Science and a Research Director of the European Observatory on Health Systems and Policies. Monique Mrazek is a Health Economist (Europe and Central Asia region) for the World Bank and formerly a Research Officer in Health Economics for the European Observatory on Health Systems and Policies. Tom Walley is Professor of Clinical Pharmacology at the University of Liverpool and Director of the UK National Health Technology Assessment Programme. Contributors: Julia Abelson, Christa Altenstetter, Vittorio Bertele’, Christine Bond, Marcel L. Bouvy, Colin Bradley, Steve Chapman, Anna Dixon, Michael Drummond, Pierre Durieux, Edzard Ernst, Armin Fidler, Eric Fortess, Richard Frank, Silvio Garattini, Leigh Hancher, Ebba Holme Hansen, Steve Hudson, Kees de Jonchere, Panos Kanavos, Sjoerd Kooiker, Jean-Marc Leder, Graham Lewis, Donald W. Light, Alistair McGuire, Elias Mossialos, Monique Mrazek, Maria Pia Orru', Govin Permanand, Guenka Petrova, Munir Pirmohamed, Dennis Ross-Degnan, Frans Rutten, Steven Soummerai, David Taylor, Sarah Thomson, Tom Walley.
Book Synopsis FDA Bioequivalence Standards by : Lawrence X. Yu
Download or read book FDA Bioequivalence Standards written by Lawrence X. Yu and published by Springer. This book was released on 2014-09-05 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
Book Synopsis Physicians' Desk Reference for Generics, 1997 by : Medical Economics
Download or read book Physicians' Desk Reference for Generics, 1997 written by Medical Economics and published by PDR Network. This book was released on 1997-01-01 with total page 3500 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference provides prescribing and pricing information on every recognized prescription medicine on the market. Covering nearly 24,000 medications, both brand and generic: common off-label uses of drugs - identifies conditions that can be treated with drugs that actually have FDA-approved and labeled for another condition; costs-of-therapy tables - a practical look at the daily cost of therapy for the most common indications for which medications are prescribed; an international drug-name index - an index of 15,000 international drug brand names, cross-referenced to their US equivalents; three comprehensive indices let readers look up information by brand and generic drug name, therapeutic category and indication; all major products and FDA bioequivalent alternatives are listed - grouped by strength and form with their NDC number, package size and AWP pricing - brand and generic average unit prices are available where appropriate for quick comparison of generic substitution; visual identification guides - over 7000 drug imprints help make positive identification of unmarked prescription drugs.
Download or read book The National Formulary written by and published by . This book was released on 1955 with total page 920 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Description and Analysis of the VA National Formulary by : Institute of Medicine
Download or read book Description and Analysis of the VA National Formulary written by Institute of Medicine and published by National Academies Press. This book was released on 2000-10-03 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: The VA National Formulary generated controversy, which motivated congressional scrutiny and a directive to the VA to commission this report reviewing the experience with the National Formulary and formulary system. This Institute of Medicine committee was pleased to assist the Congress with this review, in part because the committee saw in the VHA example an opportunity to understand and anticipate problems that all publicly funded programs are likely to encounter in this new age of pharmaceuticals. The Congress asked the committee to review the restrictiveness of the National Formulary, its impact on the costs and quality of care in the VHA, and how it compared to formularies and drug management practices in the private sector and in other public programs, especially Medicaid. Detailed in the pages that follow, the committee's findings and conclusions on these questions are, the committee believes, highly instructive, though not always in the ways that we anticipated.
Download or read book Bottle of Lies written by Katherine Eban and published by HarperCollins. This book was released on 2020-06-23 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 New postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.
