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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: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Medical
Languages : en
Pages : 656
Get Book Here
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: Barton Cobert
Publisher: Jones & Bartlett Publishers
ISBN: 0763791601
Category : Medical
Languages : en
Pages : 431
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Book Description
Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacuetucal, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem.
Author: Michael J. Klepper
Publisher: Jones & Bartlett Publishers
ISBN: 1449671551
Category : Medical
Languages : en
Pages : 332
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Book Description
Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 1119097401
Category : Medical
Languages : en
Pages : 918
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Book Description
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Author: Barton Cobert
Publisher: World Scientific
ISBN: 9813279168
Category : Medical
Languages : en
Pages : 525
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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.Related Link(s)
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309103045
Category : Medical
Languages : en
Pages : 347
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Book Description
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author: Sabrina Nour
Publisher: Academic Press
ISBN: 012816381X
Category : Medical
Languages : en
Pages : 240
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Book Description
Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. - Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs - Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions - Offers case studies that illustrate real-life clinical situations - Discusses important concepts related to pharmacoepidemiology and pharmacovigilance
Author: Stephen E Wolverton
Publisher: Elsevier Health Sciences
ISBN: 0323612121
Category : Medical
Languages : en
Pages : 1073
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Book Description
Designed with practical usability in mind, Comprehensive Dermatologic Drug Therapy, 4th Edition, helps you safely and effectively treat the skin disorders you're likely to see in your practice. Dr. Stephen E. Wolverton and new associate editor Dr. Jashin J. Wu lead a team of global experts to bring you concise, complete guidance on today's full spectrum of topical, intralesional, and systemic drugs. You'll prescribe with confidence thanks to expert coverage of which drugs to use, when to use them, and adverse effects to monitor. - Includes new drug interaction tables, drug risk profiles, and FDA guidelines, as well as two new appendices that summarize chapter questions and summarize highest-risk drug interactions. - Covers the best uses for new biologic therapeutics. - Contains new chapters covering medical decision-making principles, PDE-4 and JAK inhibitors, interleukin 17 inhibitors, interleukin 23 inhibitors, additional biologic therapeutics, and hedgehog pathway inhibitors. - Contains quick-access summaries of indications/contraindications, dosage guidelines, drug interactions, drug monitoring guidelines, adverse effects, and treatment protocols. - Features a highly detailed, disease-specific index, as well as purchase information for major drugs. - Helps you assess your knowledge and prepare for certification or recertification with about 800 review questions and answers throughout the book. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309218160
Category : Medical
Languages : en
Pages : 292
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Book Description
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Author: Stephanie Saunders
Publisher: Elsevier Health Sciences
ISBN: 0702048348
Category : Medical
Languages : en
Pages : 266
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Book Description
Now in its fourth edition and with a new title – Injection Techniques in Musculoskeletal Medicine – this successful step-by-step guide is a trusted resource used by a wide range of practitioners who have to deal with the management of painful joints and soft tissues, particularly in relation to sports and overuse injuries. Area by area, guidance is given for each lesion on appropriate patient selection and delivery of the drug. Every technique has its own two-page spread containing a written description along with an anatomical illustration of the region and a photograph showing the anatomical landmarks for the injection. This new edition is now accompanied by a Trainer available via www.injectiontechniquesonline.com. Please see log on for further details on how to access the virtual training guide - introduced by Stephanie Saunders herself - which covers the top most common injection techniques for each of the body regions. Through key text, videos, animations and interactive self-assessment, users are tested on their knowledge of anatomical landmarks, differential diagnoses, assessment criteria, drug selection and technical skill. Further access is given to a library of over 50 video clips showing supplementary injection techniques which clearly demonstrate the correct anatomical position for each needle insertion. Illustrations, references, lesions, drugs, controversies! Chapters on Other Injectable Substances; Landmark and Image Guided Injections Latest evidence in injection therapy literature Adapted and simplified practical sections Access to Musculoskeletal Injection Techniques Trainer – a virtual aid to test your anatomical and technical skills on the top most common injections for the upper and lower limbs and spine – perfect for self-testing and honing your skills! Log on to www.injectiontechniquesonline.com to begin The Trainer also gives unlimited access to a bank of over 50 video clips demonstrating actual needle insertion for each lesion
