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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377
Get Book Here
Book Description
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.
Author: Mark Davison
Publisher: John Wiley & Sons
ISBN: 1118023668
Category : Medical
Languages : en
Pages : 432
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Book Description
This book overviews and integrates the business and technical issues that pharmaceutical companies need to know in order to combat the major global problem of counterfeit medicines. In addition to discussion of the problems, the author Davison addresses analytical techniques scientists use to detect counterfeits and presents some possible solutions to the threat of counterfeit medical products. Coverage moves from basic overview of the problem, costs / risks to consumers (toxic products, mistrust of drug companies) and business (revenue loss, public trust), government oversight and regulation, authentication strategies (packaging, analytical techniques), product tracking and supply chain, and case studies from around the globe.
Author: United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Counterfeits and counterfeiting
Languages : en
Pages : 432
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Book Description
Author: Muhammad H. Zaman
Publisher: Oxford University Press
ISBN: 0190219459
Category : Science
Languages : en
Pages : 281
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Book Description
Long the scourge of developing countries, fake pills are now increasingly common in the United States. The explosion of Internet commerce, coupled with globalization and increased pharmaceutical use has led to an unprecedented vulnerability in the U.S. drug supply. Today, an estimated 80% of our drugs are manufactured overseas, mostly in India and China. Every link along this supply chain offers an opportunity for counterfeiters, and increasingly, they are breaking in. In 2008, fake doses of the blood thinner Heparin killed 81 people worldwide and resulted in hundreds of severe allergic reactions in the United States. In 2012, a counterfeit version of the cancer drug Avastin, containing no active chemotherapy ingredient, was widely distributed in the United States. In early 2013, a drug trafficker named Francis Ortiz Gonzalez was sentenced to prison for distributing an assortment of counterfeit, Chinese-made pharmaceuticals across America. By the time he was arrested, he had already sold over 140,000 fake pills to customers. Even when the U.S. system works, as it mostly does, consumers are increasingly circumventing the safeguards. Skyrocketing health care costs in the U.S. have forced more Americans to become "medical tourists" seeking drugs, life-saving treatments and transplants abroad, sometimes in countries with rampant counterfeit drug problems and no FDA. Bitter Pills will heighten the public's awareness about counterfeit drugs, critically examine possible solutions, and help people protect themselves. Author Muhammad H. Zaman pays special attention to the science and engineering behind both counterfeit and legitimate drugs, and the role of a "technological fix" for the fake drug problem. Increasingly, fake drugs affect us all.
Author: Pulok K. Mukherjee
Publisher: Elsevier
ISBN: 0128133988
Category : Science
Languages : en
Pages : 788
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Book Description
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
Author: Jiben Roy
Publisher: Elsevier
ISBN: 1908818042
Category : Medical
Languages : en
Pages : 449
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Book Description
This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences.This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry.A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry. - Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions - Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes - Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries
Author: Katherine Eban
Publisher: HarperCollins
ISBN: 0063054108
Category : Medical
Languages : en
Pages : 523
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Book Description
A NEW YORK TIMES BESTSELLER * New York Times Notable Book * Best Book of the Year: New York Public Library, Kirkus Reviews, Science Friday With a 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.
Author: OECD
Publisher: OECD Publishing
ISBN: 926404552X
Category :
Languages : en
Pages : 399
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Book Description
This study develops and applies a rigorous methodology to estimate the incidence of counterfeit and pirated items in world trade.
Author: United States. Congress. House. Committee on Commerce
Publisher:
ISBN:
Category :
Languages : en
Pages : 368
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Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235
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Book Description
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.
