Regulation Of Over The Counter Drugs

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Pain Management and the Opioid Epidemic

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine

Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Making Medicines Affordable

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)

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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.

Non-prescription Medicines

Author : Alan Nathan
Publisher : Pharmaceutical Press
ISBN 13 : 0853698864
Total Pages : 321 pages
Book Rating : 4.8/5 (536 download)

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Book Synopsis Non-prescription Medicines by : Alan Nathan

Download or read book Non-prescription Medicines written by Alan Nathan and published by Pharmaceutical Press. This book was released on 2010 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition of Non-prescription Medicines has been revised and updated to reflect amendments in legal category status of several products from prescription-only (POM) to pharmacy sale (P) status. Over-the-counter (OTC) medicines currently available in the UK are reviewed in alphabetically arranged chapters on the conditions that they are licensed to treat. 44 common conditions are covered and new chapters on Chlamydia, Obesity and Benign Prostatic Hyperplasia have been added. Each chapter includes:* an introduction to the condition* detailed description of the available products, including mode of action, side-effects, cautions and contraindications, interactions and dosage* product selection points* product recommendations. Non-prescription Medicines is the only publication in the UK that deals with available OTC medicines comprehensively and in depth. This vital resource will enable pharmacists, GPs, nurses and other healthcare professionals to make well-informed recommendations and to give sound advice to their patients. Updates are available online in January and June at (INSERT WEB ADDRESS)Alan Nathan is a freelance pharmacy writer and Consultant, London, UK.

Quality Control and Evaluation of Herbal Drugs

Author : Pulok K. Mukherjee
Publisher : Elsevier
ISBN 13 : 0128133988
Total Pages : 788 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Quality Control and Evaluation of Herbal Drugs by : Pulok K. Mukherjee

Download or read book Quality Control and Evaluation of Herbal Drugs written by Pulok K. Mukherjee and published by Elsevier. This book was released on 2019-05-30 with total page 788 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Control and Evaluation of Herbal Drugs brings together current thinking and practices for evaluation of natural products and traditional medicines. The use of herbal medicine in therapeutics is on the rise in both developed and developing countries and this book facilitates the necessary development of quality standards for these medicines.This book elucidates on various challenges and opportunities for quality evaluation of herbal drugs with several integrated approaches including metabolomics, chemoprofiling, marker analysis, stability testing, good practices for manufacturing, clinical aspects, Ethnopharmacology and Ethnomedicine inspired drug development. Written by Prof. Pulok K Mukherjee, a leader in this field; the book highlights on various methods, techniques and approaches for evaluating the purity, quality, safety and efficacy of herbal drugs. Particular attention is paid to methods that assess these drugs' activity, the compounds responsible and their underlying mechanisms of action. The book describes the quality control parameters followed in India and other countries, including Japan, China, Bangladesh, and other Asian countries, as well as the regulatory profiles of the European Union and North America. This book will be useful in bio-prospecting of natural products and traditional medicine-inspired drug discovery and development. - Provides new information on the research and development of natural remedies - essential reading on the study and use of natural resources for preventative or healing purposes - Brings together current thinking and practices in quality control and standardization of herbal drugs highlighting several integrated approaches for metabolomics, chemo-profiling and marker analysis - Aids in developing knowledge of various techniques including macroscopy, microscopy, HPTLC, HPLC, LC-MS/MS, GC-MS etc. with the development of integrated methods for evaluation of botanicals used in traditional medicine - Assessment of herbal drugs through bio-analytical techniques, bioassay guided isolation, enzyme inhibition, pharmacological, microbiological, antiviral assays and safety related quality issues - References global organizations, such as the WHO, USFDA, CDSCO, AYUSH, TCM and others to serve as a comprehensive document for enforcement agencies, NGOs and regulatory authorities

Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality

Author : Mossialos, Elias
Publisher : McGraw-Hill Education (UK)
ISBN 13 : 0335214657
Total Pages : 390 pages
Book Rating : 4.3/5 (352 download)

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Book Synopsis Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality by : Mossialos, Elias

Download or read book Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality written by Mossialos, Elias and published by McGraw-Hill Education (UK). This book was released on 2004-06-01 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 Berteleâ€™, 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.

Compounded Topical Pain Creams

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 030967218X
Total Pages : 353 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Compounded Topical Pain Creams by : National Academies of Sciences, Engineering, and Medicine

Download or read book Compounded Topical Pain Creams written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-07-21 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

Evidence-Based Validation of Herbal Medicine

Author : Pulok K. Mukherjee
Publisher : Elsevier
ISBN 13 : 0323984568
Total Pages : 858 pages
Book Rating : 4.3/5 (239 download)

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Book Synopsis Evidence-Based Validation of Herbal Medicine by : Pulok K. Mukherjee

Download or read book Evidence-Based Validation of Herbal Medicine written by Pulok K. Mukherjee and published by Elsevier. This book was released on 2022-07-12 with total page 858 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evidence-Based Validation of Herbal Medicines: Translational Research on Botanicals brings together current thinking and practice in the characterization and validation of natural products. The book describes different approaches and techniques for evaluating the quality, safety and efficacy of herbal medicine, particularly methods to assess their activity and understand compounds responsible and their probable underlying mechanisms of action. This book brings together the views, expertise and experiences of scientific experts in the field of medicinal plant research, hence it will be useful for researcher who want to know more about the natural lead with their validation and also useful to exploit traditional medicines. - Includes state-of-the-art methods for detecting, isolating and performing structure elucidation by degradation and spectroscopic techniques - Highlights the trends in validation and value addition of herbal medicine with different scientific approaches used in therapeutics - Contains several all-new chapters on topics such as traditional-medicine-inspired drug development to treat emerging viral diseases, medicinal plants in antimicrobial resistance, TLC bio profiling, botanicals as medicinal foods, bioprospecting and bioassay-guided isolation of medicinal plants, immunomodulators from medicinal plants, and more

Dietary Supplements

Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Dietary Supplements by : United States. Federal Trade Commission. Bureau of Consumer Protection

Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

An Overview of FDA Regulated Products

Author : Eunjoo Pacifici
Publisher : Academic Press
ISBN 13 : 0128111569
Total Pages : 292 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis An Overview of FDA Regulated Products by : Eunjoo Pacifici

Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Encyclopedia of Pharmacy Practice and Clinical Pharmacy

Author :
Publisher : Academic Press
ISBN 13 : 0128127368
Total Pages : 2370 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Encyclopedia of Pharmacy Practice and Clinical Pharmacy by :

Download or read book Encyclopedia of Pharmacy Practice and Clinical Pharmacy written by and published by Academic Press. This book was released on 2019-06-28 with total page 2370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Encyclopedia of Pharmacy Practice and Clinical Pharmacy, Three Volume Set covers definitions, concepts, methods, theories and applications of clinical pharmacy and pharmacy practice. It highlights why and how this field has a significant impact on healthcare. The work brings baseline knowledge, along with the latest, most cutting-edge research. In addition, new treatments, algorithms, standard treatment guidelines, and pharmacotherapies regarding diseases and disorders are also covered. The book's main focus lies on the pharmacy practice side, covering pharmacy practice research, pharmacovigilance, pharmacoeconomics, social and administrative pharmacy, public health pharmacy, pharmaceutical systems research, the future of pharmacy, and new interventional models of pharmaceutical care. By providing concise expositions on a broad range of topics, this book is an excellent resource for those seeking information beyond their specific areas of expertise. This outstanding reference is essential for anyone involved in the study of pharmacy practice. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the field Meticulously organized, with articles split into three clear sections, it is the ideal resource for students, researchers and professionals to find relevant information Contains concise and accessible chapters that are ideal as an authoritative introduction for non-specialists and readers from the undergraduate level upwards Includes multimedia options, such as hyperlinked references and further readings, cross-references and videos

Regulation of Over-the-counter Drugs

Author : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Oversight and Investigations
Publisher :
ISBN 13 :
Total Pages : 134 pages
Book Rating : 4.0/5 (18 download)

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Book Synopsis Regulation of Over-the-counter Drugs by : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Oversight and Investigations

Download or read book Regulation of Over-the-counter Drugs written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 1979 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt:

International Conference on Advancements of Medicine and Health Care through Technology; 12th - 15th October 2016, Cluj-Napoca, Romania

Download International Conference on Advancements of Medicine and Health Care through Technology; 12th - 15th October 2016, Cluj-Napoca, Romania PDF Online Free

Author : Simona Vlad
Publisher : Springer
ISBN 13 : 3319528750
Total Pages : 371 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis International Conference on Advancements of Medicine and Health Care through Technology; 12th - 15th October 2016, Cluj-Napoca, Romania by : Simona Vlad

Download or read book International Conference on Advancements of Medicine and Health Care through Technology; 12th - 15th October 2016, Cluj-Napoca, Romania written by Simona Vlad and published by Springer. This book was released on 2017-03-15 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume presents the contributions of the fifth International Conference on Advancements of Medicine and Health Care through Technology (Meditech 2016), held in in Cluj-Napoka, Romania. The papers of this Proceedings volume present new developments in - Health Care Technology, - Medical Devices, Measurement and Instrumentation, - Medical Imaging, Image and Signal Processing, - Modeling and Simulation, - Molecular Bioengineering, - Biomechanics.

Approved Prescription Drug Products

Author :
Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Approved Prescription Drug Products by :

Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1984 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.

Countering the Problem of Falsified and Substandard Drugs

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309269393
Total Pages : 377 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Countering the Problem of Falsified and Substandard Drugs by : Institute of Medicine

Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Biodesign

Author : Stefanos Zenios
Publisher : Cambridge University Press
ISBN 13 : 0521517427
Total Pages : 779 pages
Book Rating : 4.5/5 (215 download)

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Book Synopsis Biodesign by : Stefanos Zenios

Download or read book Biodesign written by Stefanos Zenios and published by Cambridge University Press. This book was released on 2010 with total page 779 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.

Bottle of Lies

Author : Katherine Eban
Publisher : HarperCollins
ISBN 13 : 0063054108
Total Pages : 512 pages
Book Rating : 4.0/5 (63 download)

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Book Synopsis Bottle of Lies by : Katherine Eban

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.

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309157277
Total Pages : 335 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease by : Institute of Medicine

Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.