Pharmacovigilance And Pharmacoepidemiology Public Health And Safety
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Pharmacovigilance And Pharmacoepidemiology Public Health And Safety
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Author : Thierry Trenque
language : en
Publisher: Frontiers Media SA
Release Date : 2024-06-24
Pharmacovigilance And Pharmacoepidemiology Public Health And Safety written by Thierry Trenque and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-06-24 with Science categories.
Pharmacovigilance has historically been based on spontaneous reports. The World Health Organisation (WHO) defines pharmacovigilance as "the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any medicine-related problem" (WHO 2004). Pharmacoepidemiological studies can supplement the role of identification, as the spontaneous reporting of adverse drug reactions and conventional pharmacovigilance, can alert us to other, potentially more major, problems, medicine-related or otherwise.
Pharmacoepidemiology
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Author : Brian L. Strom
language : en
Publisher: John Wiley & Sons
Release Date : 2006-01-04
Pharmacoepidemiology written by Brian L. Strom and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-01-04 with Medical categories.
The fourth edition of Pharmacoepidemiology is an outstandingand fully comprehensive textbook, which will be an essentialresource for all interested in the field—in academia, inregulatory agencies, in industry and in the law. BrianStrom’s classic textbook continues both to reflect theincreased maturation of pharmacoepedemiology and to help shapeit’s direction. Reviews of previous editions of his celebrated textbookinclude: "The book is essential reading for anyone interested inpharmacoepidemiology." INTERNATIONAL JOURNAL OF EPIDEMIOLOGY “…an excellent textbook and a comprehensivereference which belongs in the library of everypharmaceutical manufacturer and regulator." EUROPEAN JOURNAL OF PUBLIC HEALTH
Databases For Pharmacoepidemiological Research
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Author : Miriam Sturkenboom
language : en
Publisher: Springer Nature
Release Date : 2021-01-12
Databases For Pharmacoepidemiological Research written by Miriam Sturkenboom and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-12 with Medical categories.
This book allows readers to gain an in-depth understanding of the role of real-world data in pharmacoepidemiology, and highlights the strengths and limitations of the respective databases with regard to pharmacoepidemiological research. Over the past decade, the increasing use of real-world data in pharmacoepidemiological research has been accompanied by a growing recognition of the value of real-world evidence in clinical and regulatory decision-making. Electronic healthcare databases allow analyses of drug and vaccine utilization in routine care after approval, as well as investigations of their comparative effectiveness and safety. They are especially useful for the identification of rare risks and rare drug exposures over long periods of time, and as such sustainably extend the basis for drug safety research. This book provides an introduction to the role of real-world data in pharmacoepidemiological research and the main developments in the last 15 years. It also offers a comprehensive overview of the general classification characteristics of databases, together with their strengths and limitations, and a detailed description of 21 individual databases, written by professionals who work with or maintain them.
An Introduction To Pharmacovigilance
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Author : Patrick Waller
language : en
Publisher: John Wiley & Sons
Release Date : 2017-02-14
An Introduction To Pharmacovigilance written by Patrick Waller and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-14 with Medical categories.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.
New Insights Into The Future Of Pharmacoepidemiology And Drug Safety
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Author : Maria Teresa Herdeiro
language : en
Publisher: BoD – Books on Demand
Release Date : 2021-10-13
New Insights Into The Future Of Pharmacoepidemiology And Drug Safety written by Maria Teresa Herdeiro and has been published by BoD – Books on Demand this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-13 with Medical categories.
In the last decade, pharmacoepidemiology has emerged as an important field to study the use/effects of drugs in large populations in real life, allowing for improved benefits and effectiveness of drugs as well as a decline in drug-related risks. The correct assessment, reporting, monitoring, and prevention of adverse events in drugs’ development, as well as therapy and post-market surveillance, is essential to improve clinical therapies and health outcomes. This book provides a comprehensive and unique overview of the relevance, new insights, and recent findings of pharmacoepidemiology and drug safety in public health.
Pharmacoepidemiology And Pharmacovigilance
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Author : Sabrina Nour
language : en
Publisher: Academic Press
Release Date : 2018-10-17
Pharmacoepidemiology And Pharmacovigilance written by Sabrina Nour and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-17 with Medical categories.
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
Practical Drug Safety From A To Z
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Author : Barton Cobert
language : en
Publisher: Jones & Bartlett Publishers
Release Date : 2009-10-06
Practical Drug Safety From A To Z written by Barton Cobert and has been published by Jones & Bartlett Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-10-06 with Medical categories.
The Practical Drug Safety from A to Z is an alphabetical guide to drug safety monitoring (pharmacovigilance), covering literally, the "A to Z" of maintaining drug safety. Written by experts in the field, this book is a perfect to companion to the Manual of Drug Safety and Pharmacovigilance and an essential reference for pharmacists, pharmacologists, hospital administrators, medical liability lawyers, and others.
Textbook Of Pharmacoepidemiology
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Author : Brian L. Strom
language : en
Publisher: John Wiley & Sons
Release Date : 2013-05-13
Textbook Of Pharmacoepidemiology written by Brian L. Strom and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-13 with Medical categories.
The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies Designed for students with basic knowledge of epidemiology and public health Includes many case studies to illustrate pharmacoepidemiology in real clinical setting
Dictionary Of Pharmacovigilance
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Author : Amer Alghabban
language : en
Publisher:
Release Date : 2004
Dictionary Of Pharmacovigilance written by Amer Alghabban and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Medical categories.
Pharmacovigilance is, in essence, the process of monitoring the everyday use of medicines to identify previously unrecognised adverse drug reactions, thereby assessing their risk/benefit balance in order to determine what action, if any, is necessary to improve their safe use. As a discipline, pharmacovigilance impacts on many specialist areas such as pharmacoepidemiology, medical practice, public health, but is most intimately linked to clinical research, development and drug licensing. The discipline along with its operational and legal facets, for both regulatory authorities and pharmaceutical industry, envelop colossal terminology that has precise legal and scientific significance. Such terminology may vary from country to country, or more confusingly, different countries may use identical or similar abbreviations, terms or phrases to mean different entities.The Dictionary of Pharmacovigilance contains a comprehensive list of abbreviations, terms and phrases (in English) giving definitions of commonly (and rarely) encountered pharmacovigilance terms. Examples include: Absolute Risk Increase (ARI), Bayesian Confidence Propagation Neural Network (BCPNN), Confounding Factor, Case narrative, Causality Assessment, Company Core Safety Information (CCSI), Data mining, 15-day report, Rechallenge, Directive 2001/83/EC, EU Birth Date, Expert report, FDA Form 1639, Historical control, Number Needed to Harm, Toxikinetics, Post-Marketing Surveillance, Qualified Person, Source Data Verification (SDV), Spontaneous Reporting, Vaccine Adverse Event Reporting System (VAERS), Warning Letter, Product Withdrawal.
Pharmacovigilance
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Author : Ronald D. Mann
language : en
Publisher: John Wiley & Sons
Release Date : 2007-02-06
Pharmacovigilance written by Ronald D. Mann and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-02-06 with Medical categories.
Written by an international team of outstanding editors andcontributors, Pharmacovigilance, 2ndEdition is the definitive text on this importantsubject. The new edition has been completely revised andupdated to include the latest theoretical and practical aspects ofpharmacovigilance including legal issues, drug regulatoryrequirements, methods of signal generation, reporting schemes andpharmacovigilance in selected system-organ classes. . The editors and contributors are of excellent standing withinthe pharmacovigilance community The text provides exemplary coverage of all the relevantissues The definitive book on the subject