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Drug Safety In Developing Countries

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Drug Safety in Developing Countries

Drug Safety in Developing Countries Book
Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
Release : 2020-06-04
ISBN : 9780128198377
Language : En, Es, Fr & De

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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

Drug Safety in Developing Countries

Drug Safety in Developing Countries Book
Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
Release : 2020-06-03
ISBN : 0128204125
Language : En, Es, Fr & De

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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

Global Health Interventions for U S Food and Drug Safety

Global Health Interventions for U S  Food and Drug Safety Book
Author : Anonim
Publisher : Unknown
Release : 2009
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Global Health Interventions for U S Food and Drug Safety book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Book
Author : Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries
Publisher : National Academies Press
Release : 2012-09-03
ISBN : 030922408X
Language : En, Es, Fr & De

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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.

Patents and Pharmaceutical Drugs

Patents and Pharmaceutical Drugs Book
Author : Julio J. Nogués
Publisher : World Bank Publications
Release : 1990
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Patents and Pharmaceutical Drugs book written by Julio J. Nogués, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Promoting Safety of Medicines for Children

Promoting Safety of Medicines for Children Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2007
ISBN : 9241563435
Language : En, Es, Fr & De

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Book Description :

Monitoring the safety of medicine use in children is of paramount importance since, during the clinical development of medicines, only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation, indications, contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in the pediatric populations. This book will be of interest to all health care professionals, medicine regulatory authorities, pharmacovigilance centers, academia, the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.--Publisher's description.

Social and Administrative Aspects of Pharmacy in Low and Middle Income Countries

Social and Administrative Aspects of Pharmacy in Low  and Middle Income Countries Book
Author : Mohamed Izham Mohamed Ibrahim,Albert Wertheimer,Zaheer-Ud-Din Babar
Publisher : Academic Press
Release : 2017-10-31
ISBN : 0128112298
Language : En, Es, Fr & De

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Book Description :

Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries: Present Challenges and Future Solutions examines the particularities of low- and middle-income countries and offers solutions based on their needs, culture and available resources. Drawing from the firsthand experience of researchers and practitioners working in these countries, this book addresses the socio-behavioral aspects of pharmacy and health, pharmacoeconomics, pharmaceutical policy, supply management and marketing, pharmacoepidemiology and public health pharmacy specific to low- and middle-income countries. While some practices may be applied appropriately in disparate places, too often pharmacy practice in low- and middle-income countries is directly copied from successes in developed countries, despite the unique needs and challenges low- and middle-income countries face. Examines key issues and challenges of pharmacy practice and the pharmaceutical sector specific to low- and middle-income countries Compares pharmacy practice in developed and developing countries to highlight the unique challenges and opportunities of each Provides a blueprint for the future of pharmacy in low- and middle-income countries, including patient-centered care, evidence-based care and promoting the role of the pharmacist for primary health care in these settings

Monitoring for Drug Safety

Monitoring for Drug Safety Book
Author : William Howard Wallace Inman
Publisher : Unknown
Release : 1980
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Monitoring for Drug Safety book written by William Howard Wallace Inman, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Drug Surveillance

Drug Surveillance Book
Author : Zbigniew Bańkowski,John F. Dunne
Publisher : World Health Organization
Release : 1993-12-31
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Records the proceedings of an international conference convened to consider mechanisms for improving international cooperation in the surveillance of drug safety and the reporting of adverse reactions. Attended by close to 200 representatives of regulatory authorities and the pharmaceutical industry as well as clinical pharmacologists, the conference aimed to identify the strengths and weaknesses of existing mechanisms for international cooperation and to propose improvements for the future.

Drug Labeling in Developing Countries

Drug Labeling in Developing Countries Book
Author : United States
Publisher : Congress
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Drug Labeling in Developing Countries book written by United States, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Drug Safety Amendments of 1976

Drug Safety Amendments of 1976 Book
Author : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment
Publisher : Unknown
Release : 1976
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Drug Safety Amendments of 1976 book written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Responsibility for Drug induced Injury

Responsibility for Drug induced Injury Book
Author : Graham Dukes,Maurice Nelson Graham Dukes,Mark Mildred,Barbara Swartz
Publisher : IOS Press
Release : 1998
ISBN : 9789051993875
Language : En, Es, Fr & De

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Book Description :

This edition reflects the evolution of legal standards, professional rules, industrial codes of ethics, and court experience in cases involving recompense for medical injury since the 1988 version. While deriving from legal standards of the US, British Commonwealth, European Union, and Nordic Council, a chapter is devoted to issues particular to developing countries. Following an introductory chapter on the emergence and recognition of problems relating to drug safety, 20 chapters cover such areas as: the legal framework (types of proceedings, evidence, and proof); the responsibility of everyone from the government and manufacturer to the prescriber and patient; clinical investigation of drugs; controlled drugs; self-medication; alternative and complementary medicine; and vaccines and biologicals. Includes a table of cases, and table of conventions, statutes, and regulations. Annotation copyrighted by Book News, Inc., Portland, OR

Food and Drug Regulation in an Era of Globalized Markets

Food and Drug Regulation in an Era of Globalized Markets Book
Author : Sam F Halabi
Publisher : Academic Press
Release : 2015-08-31
ISBN : 0128025506
Language : En, Es, Fr & De

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Book Description :

Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today’s markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O’Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation. Interdisciplinary approach allows readers to understand the varying perspectives involved in regulatory development Includes case studies to highlight harmonization efforts and challenges, and to provide practical insights for application going forward Provides a thorough assessment of supply chains, potential gaps, and means of anticipating and addressing issues Presents a comprehensive snapshot of changes in the food safety law in the United States and under international standards, including academic, industry and regulatory perspectives Addresses conflicts and cooperation between relevant US agencies including USDA, FDA, DEA, EPA, FTC and the Department of Commerce

Industrial Guide to Chemical and Drug Safety

Industrial Guide to Chemical and Drug Safety Book
Author : T. S. S. Dikshith,Prakash V. Diwan
Publisher : John Wiley & Sons
Release : 2003-05-27
ISBN : 0471458775
Language : En, Es, Fr & De

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Book Description :

Exposure to a wide variety of chemicals and drugs has become common in industrial, laboratory, and even household environments. Fortunately, global understanding and consequently global safety standards regarding the management of toxic and hazardous substances are fast approaching uniformity. The methods of handling, use, transportation, storage, and disposal in particular are moving toward standardization. As these protocols involving chemicals and drugs continue to cross international borders, students and professionals need a reliable resource to ensure they observe appropriate safety standards. The Industrial Guide to Chemical and Drug Safety covers not only current standards, but also a wealth of information on toxins to help regulatory bodies develop new protocols. Written in an accessible narrative style, the Guide covers chemicals by key classes such as solvents, pesticides, and metals, and also by key industries such as drugs, food additives, plastics, cosmetics, detergents, and soaps. The book explains the beneficial and harmful aspects of a broad range of materials to which students, trainees, skilled workers, managers, and personnel associated with regulatory agencies are exposed, with the purpose of helping them avoid the illnesses associated with the misuse of chemicals and drugs. Chapters include: -Heavy Metals -Pesticides -Industrial Solvents -Industrial Gases and Fumes -Drugs -Target Organ Toxicity -Disposal of Hazardous Chemicals -Guidance to Students and Workers -Good Laboratory Practice

Practical Drug Safety from A to Z

Practical Drug Safety from A to Z Book
Author : Barton Cobert,Pierre Biron
Publisher : Jones & Bartlett Publishers
Release : 2009-10-06
ISBN : 0763745278
Language : En, Es, Fr & De

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Book Description :

The Dictionary of Drug Safety and Pharmacovigilance is an alphabetical guide to drug safety monitoring (pharmacovigilance), covering literally, the

Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition

Cobert s Manual Of Drug Safety And Pharmacovigilance  Third Edition  Book
Author : Cobert Barton,Gregory William,Thomas Jean-loup
Publisher : World Scientific
Release : 2019-04-10
ISBN : 9813279168
Language : En, Es, Fr & De

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Book Description :

Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.

Comparative Analysis of French and Vietnamese Pharmacovigilance Databases with Pharmacoepidemiological Application and Improvement of the Underreporting of Adverse Drug Reactions in Vietnam

Comparative Analysis of French and Vietnamese Pharmacovigilance Databases with Pharmacoepidemiological Application and Improvement of the Underreporting of Adverse Drug Reactions in Vietnam Book
Author : Khac Dung Nguyen
Publisher : Unknown
Release : 2018
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

The understanding and quantitative analysis in drug safety domain among developing countries remain still limited. The creation of the National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) of Vietnam in 2009 was a landmark for the pharmacovigilance activities in this country and allowed the registration of spontaneous adverse drug reaction (ADR) reports. The accumulation of National Pharmacovigilance Database of Vietnam (NPDV) requires a quantitative and qualitative analysis and generation of pharmacovigilance signals to better protect Vietnamese people's health. The main objectives of the thesis are: (i) describe the Vietnamese pharmacovigilance system, with the comparison to another developed pharmacovigilance system as a reference (France), (ii) apply a set of pharmacoepidemiological approaches to identify the specific drug-related risks, and (iii) improve the under-reporting issue in Vietnam. Firstly, we introduce a full-detailed overview of Vietnamese pharmacovigilance system with a series of lessons learned for the other countries sharing the similar limited-resource context. Some achievements and challenges for the sustainable development of the system were also equitably discussed. Secondly, we used the Vietnamese and French pharmacovigilance databases to compare the differences in characteristics of two types of ADR: anaphylaxis and Steven-Johnson's syndrome and toxic epidermal necrolysis (SJS/TEN) induced by medications. Next, we generated the first Vietnamese pharmacovigilance signals. The signals of drug-induced SJS/TEN were generated with allopurinol, carbamazepine, traditional or herbal drugs, colchicine, valproic acid and meloxicam which were similar to the other previously studies in literature. Furthermore, we also found the significant signals of cefixime and paracetamol. For drug-induced anaphylaxis, we identified 4873 (13.2%) cases in the Vietnamese database during the period 2010-2016 with an increasing trend over time. The antibiotics (especially the third-generation cephalosporins) were the main causes of drug-induced anaphylaxis in Vietnam. In addition, the signals were generated with several drugs such as alpha-chymotrypsin, amoxicillin/sulbactam and glucose or electrolyte solutions which were typical for the resource-restricted countries. On the other hand, the identification of ADR through the screening the laboratory test results could help to increase the ADR reporting rate in Vietnam. [...].

Drug Safety and Pricing

Drug Safety and Pricing Book
Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher : Unknown
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Drug Safety and Pricing book written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.