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
Publisher : Frontiers Media SA
ISBN 13 : 2832550711
Total Pages : 190 pages
Book Rating : 4.8/5 (325 download)

Book Synopsis Pharmacovigilance and Pharmacoepidemiology: Public Health and Safety by : Thierry Trenque

Download or read book Pharmacovigilance and Pharmacoepidemiology: Public Health and Safety written by Thierry Trenque and published by Frontiers Media SA. This book was released on 2024-06-24 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Publisher : John Wiley & Sons
ISBN 13 : 0470654759
Total Pages : 977 pages
Book Rating : 4.4/5 (76 download)

Book Synopsis Pharmacoepidemiology by : Brian L. Strom

Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2012-03-05 with total page 977 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world renowned experts in the field, this valuable text surveys the research designs and sources of data available for pharmacoepidemiologic research, and provides descriptions of various automated data systems, along with the advantages and disadvantages of each. Incorporating perspectives from academia, industry and regulatory agencies, this book provides detailed insights into all aspects of pharmacoepidemiology.

Practical Drug Safety from A to Z

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Author : Barton Cobert
Publisher : Jones & Bartlett Publishers
ISBN 13 : 0763745278
Total Pages : 406 pages
Book Rating : 4.7/5 (637 download)

Book Synopsis Practical Drug Safety from A to Z by : Barton Cobert

Download or read book Practical Drug Safety from A to Z written by Barton Cobert and published by Jones & Bartlett Publishers. This book was released on 2009-10-06 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmacoepidemiology and Pharmacovigilance

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Author : Sabrina Nour
Publisher : Academic Press
ISBN 13 : 012816381X
Total Pages : 240 pages
Book Rating : 4.1/5 (281 download)

Book Synopsis Pharmacoepidemiology and Pharmacovigilance by : Sabrina Nour

Download or read book Pharmacoepidemiology and Pharmacovigilance written by Sabrina Nour and published by Academic Press. This book was released on 2018-10-17 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

New Insights into the Future of Pharmacoepidemiology and Drug Safety

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Author : Maria Teresa Herdeiro
Publisher : BoD – Books on Demand
ISBN 13 : 1839685964
Total Pages : 202 pages
Book Rating : 4.8/5 (396 download)

Book Synopsis New Insights into the Future of Pharmacoepidemiology and Drug Safety by : Maria Teresa Herdeiro

Download or read book New Insights into the Future of Pharmacoepidemiology and Drug Safety written by Maria Teresa Herdeiro and published by BoD – Books on Demand. This book was released on 2021-10-13 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

An Introduction to Pharmacovigilance

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Author : Patrick Waller
Publisher : John Wiley & Sons
ISBN 13 : 1119289750
Total Pages : 192 pages
Book Rating : 4.1/5 (192 download)

Book Synopsis An Introduction to Pharmacovigilance by : Patrick Waller

Download or read book An Introduction to Pharmacovigilance written by Patrick Waller and published by John Wiley & Sons. This book was released on 2017-02-14 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Databases for Pharmacoepidemiological Research

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Author : Miriam Sturkenboom
Publisher : Springer Nature
ISBN 13 : 3030514552
Total Pages : 276 pages
Book Rating : 4.0/5 (35 download)

Book Synopsis Databases for Pharmacoepidemiological Research by : Miriam Sturkenboom

Download or read book Databases for Pharmacoepidemiological Research written by Miriam Sturkenboom and published by Springer Nature. This book was released on 2021-01-12 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Textbook of Pharmacoepidemiology

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Author : Brian L. Strom
Publisher : John Wiley & Sons
ISBN 13 : 1118708008
Total Pages : 756 pages
Book Rating : 4.1/5 (187 download)

Book Synopsis Textbook of Pharmacoepidemiology by : Brian L. Strom

Download or read book Textbook of Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2013-05-13 with total page 756 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Pharmacovigilance

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Author : Ronald D. Mann
Publisher : John Wiley & Sons
ISBN 13 : 0470059222
Total Pages : 709 pages
Book Rating : 4.4/5 (7 download)

Book Synopsis Pharmacovigilance by : Ronald D. Mann

Download or read book Pharmacovigilance written by Ronald D. Mann and published by John Wiley & Sons. This book was released on 2007-02-06 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Mann's Pharmacovigilance

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Author : Elizabeth B. Andrews
Publisher : John Wiley & Sons
ISBN 13 : 1118820142
Total Pages : 878 pages
Book Rating : 4.1/5 (188 download)

Book Synopsis Mann's Pharmacovigilance by : Elizabeth B. Andrews

Download or read book Mann's Pharmacovigilance written by Elizabeth B. Andrews and published by John Wiley & Sons. This book was released on 2014-03-24 with total page 878 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.

Pharmacoepidemiology

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Author : Brian L. Strom
Publisher : John Wiley & Sons
ISBN 13 : 1119413419
Total Pages : 1220 pages
Book Rating : 4.1/5 (194 download)

Book Synopsis Pharmacoepidemiology by : Brian L. Strom

Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.

Dictionary of Pharmacovigilance

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Author : Amer Alghabban
Publisher :
ISBN 13 :
Total Pages : 552 pages
Book Rating : 4.3/5 (91 download)

Book Synopsis Dictionary of Pharmacovigilance by : Amer Alghabban

Download or read book Dictionary of Pharmacovigilance written by Amer Alghabban and published by . This book was released on 2004 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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: A Practical Approach

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Author : Thao Doan
Publisher : Elsevier Health Sciences
ISBN 13 : 032358117X
Total Pages : 228 pages
Book Rating : 4.3/5 (235 download)

Book Synopsis Pharmacovigilance: A Practical Approach by : Thao Doan

Download or read book Pharmacovigilance: A Practical Approach written by Thao Doan and published by Elsevier Health Sciences. This book was released on 2018-07-31 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

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Author : Cobert Barton
Publisher : World Scientific
ISBN 13 : 9813279168
Total Pages : 524 pages
Book Rating : 4.8/5 (132 download)

Book Synopsis Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) by : Cobert Barton

Download or read book Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) written by Cobert Barton and published by World Scientific. This book was released on 2019-04-10 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Cobert's Manual of Drug Safety and Pharmacovigilance

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Author : Barton Cobert
Publisher : Jones & Bartlett Publishers
ISBN 13 : 0763791598
Total Pages : 433 pages
Book Rating : 4.7/5 (637 download)

Book Synopsis Cobert's Manual of Drug Safety and Pharmacovigilance by : Barton Cobert

Download or read book Cobert's Manual of Drug Safety and Pharmacovigilance written by Barton Cobert and published by Jones & Bartlett Publishers. This book was released on 2011-04 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, pharmacology, 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.

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk

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Author : Michael J. Klepper
Publisher : Jones & Bartlett Publishers
ISBN 13 : 1449671551
Total Pages : 332 pages
Book Rating : 4.4/5 (496 download)

Book Synopsis Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk by : Michael J. Klepper

Download or read book Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk written by Michael J. Klepper and published by Jones & Bartlett Publishers. This book was released on 2010-09-15 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)

Principles and Practice of Pharmacovigilance and Drug Safety

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Author : Jimmy Jose
Publisher : Springer Nature
ISBN 13 : 3031510895
Total Pages : 557 pages
Book Rating : 4.0/5 (315 download)

Book Synopsis Principles and Practice of Pharmacovigilance and Drug Safety by : Jimmy Jose

Download or read book Principles and Practice of Pharmacovigilance and Drug Safety written by Jimmy Jose and published by Springer Nature. This book was released on with total page 557 pages. Available in PDF, EPUB and Kindle. Book excerpt: