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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: Institute of Medicine
Publisher: National Academies Press
ISBN: 030922408X
Category : Medical
Languages : en
Pages : 366
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Book Description
A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Author: Aníbal de J. Sosa
Publisher: Springer Science & Business Media
ISBN: 0387893709
Category : Science
Languages : en
Pages : 553
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Book Description
Avoiding infection has always been expensive. Some human populations escaped tropical infections by migrating into cold climates but then had to procure fuel, warm clothing, durable housing, and crops from a short growing season. Waterborne infections were averted by owning your own well or supporting a community reservoir. Everyone got vaccines in rich countries, while people in others got them later if at all. Antimicrobial agents seemed at first to be an exception. They did not need to be delivered through a cold chain and to everyone, as vaccines did. They had to be given only to infected patients and often then as relatively cheap injectables or pills off a shelf for only a few days to get astonishing cures. Antimicrobials not only were better than most other innovations but also reached more of the world’s people sooner. The problem appeared later. After each new antimicrobial became widely used, genes expressing resistance to it began to emerge and spread through bacterial populations. Patients infected with bacteria expressing such resistance genes then failed treatment and remained infected or died. Growing resistance to antimicrobial agents began to take away more and more of the cures that the agents had brought.
Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Medical
Languages : en
Pages : 656
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Book Description
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. - Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues - Describes current achievements of drug safety practice in developing countries - Addresses the challenges of drug safety in developing countries - Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety
Author: Muhammad H. Zaman
Publisher: Oxford University Press
ISBN: 0190219440
Category : Business & Economics
Languages : en
Pages : 281
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Book Description
This book will heighten the public's awareness about counterfeit drugs, critically examine possible solutions, and help people protect themselves.
Author: Richard A. Crocombe
Publisher: John Wiley & Sons
ISBN: 1119636434
Category : Science
Languages : en
Pages : 608
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Book Description
The most comprehensive resource available on the many applications of portable spectrometers, including material not found in any other published work Portable Spectroscopy and Spectrometry: Volume Two is an authoritative and up-to-date compendium of the diverse applications for portable spectrometers across numerous disciplines. Whereas Volume One focuses on the specific technologies of the portable spectrometers themselves, Volume Two explores the use of portable instruments in wide range of fields, including pharmaceutical development, clinical research, food analysis, forensic science, geology, astrobiology, cultural heritage and archaeology. Volume Two features contributions by a multidisciplinary team of experts with hands-on experience using portable instruments in their respective areas of expertise. Organized both by instrumentation type and by scientific or technical discipline, 21 detailed chapters cover various applications of portable ion mobility spectrometry (IMS), infrared and near-infrared (NIR) spectroscopy, Raman and x-ray fluorescence (XRF) spectroscopy, smartphone spectroscopy, and many others. Filling a significant gap in literature on the subject, the second volume of Portable Spectroscopy and Spectrometry: Features a significant amount of content published for the first time, or not available in existing literature Brings together work by authors with assorted backgrounds and fields of study Discusses the central role of applications in portable instrument development Covers the algorithms, calibrations, and libraries that are of critical importance to successful applications of portable instruments Includes chapters on portable spectroscopy applications in areas such as the military, agriculture and feed, hazardous materials (HazMat), art conservation, and environmental science Portable Spectroscopy and Spectrometry: Volume Two is an indispensable resource for developers of portable instruments in universities, research institutes, instrument companies, civilian and government purchasers, trainers, operators of portable instruments, and educators and students in portable spectroscopy courses.
Author: José-Luis Capelo-Martínez
Publisher: John Wiley & Sons
ISBN: 1119282527
Category : Medical
Languages : en
Pages : 730
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Book Description
This book presents a thorough and authoritative overview of the multifaceted field of antibiotic science – offering guidance to translate research into tools for prevention, diagnosis, and treatment of infectious diseases. Provides readers with knowledge about the broad field of drug resistance Offers guidance to translate research into tools for prevention, diagnosis, and treatment of infectious diseases Links strategies to analyze microbes to the development of new drugs, socioeconomic impacts to therapeutic strategies, and public policies to antibiotic-resistance-prevention strategies
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309180740
Category : Technology & Engineering
Languages : en
Pages : 73
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Book Description
A key mission of the Bureau of Engraving and Printing of the Department of the Treasury is the design and printing of U.S. banknotes. The BEP is responsible for producing easily recognizable currency that is difficult to counterfeit. In recent years, the bureau has recognized the modern information technology could lead to entirely new types of counterfeiting threats, and it has requested a number of studies by the NRC to assess these evolving threats. In this new request, the BEP asked the NRC to identify and evaluate significant emerging counterfeiting threats and to assess technologically feasible counterfeit-deterrent features for potential use in new designs. This first report provides an assessment of emerging threats including a wide range of digital imaging and printing techniques. It also presents an analysis of a systems approach to the counterfeiting threat. The second report will offer an evaluation of new banknote features to address these threats.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309110122
Category : Medical
Languages : en
Pages : 150
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Book Description
In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients. Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval. Emerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop.
Author: Ratanawijitrasin S
Publisher: World Health Organization
ISBN: 9241562064
Category : Law
Languages : en
Pages : 202
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Book Description
Seven independent variables were used including the five financing instruments, the firm's ordinary debt, and the firm's operating risk.
