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Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance
Author: Sabrina Nour
Publisher: Academic Press
Total Pages: 144
Release: 2018-10-17
Genre: Medical
ISBN: 012816381X

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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


Pharmacoepidemiology

Pharmacoepidemiology
Author: Brian L. Strom
Publisher: John Wiley & Sons
Total Pages: 912
Release: 2006-01-04
Genre: Medical
ISBN: 0470866837

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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


Textbook of Pharmacoepidemiology

Textbook of Pharmacoepidemiology
Author: Brian L. Strom
Publisher: John Wiley & Sons
Total Pages: 756
Release: 2013-05-13
Genre: Medical
ISBN: 1118708008

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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


New Insights into the Future of Pharmacoepidemiology and Drug Safety

New Insights into the Future of Pharmacoepidemiology and Drug Safety
Author: Maria Teresa Herdeiro
Publisher: BoD – Books on Demand
Total Pages: 202
Release: 2021-10-13
Genre: Medical
ISBN: 1839685964

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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.


Understanding Pharmacoepidemiology

Understanding Pharmacoepidemiology
Author: Yi Yang
Publisher: McGraw Hill Professional
Total Pages: 208
Release: 2010-12-31
Genre: Medical
ISBN: 0071766677

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A concise introduction to the study of medication utilization and safety in large populations of people Understanding Pharmacoepidemiology is a clear, engagingly written roadmap to mastering the important concepts and methods of pharmacoepidemiology. It explains what pharmacoepidemiology is, how pharmacoepidemiology studies are conducted, and how to interpret findings. You will learn the importance of pharmacoepidemiology, basic terminology used in research, and the data sources, study designs, and statistical analyses employed in pharmacoepidemiology research. Upon completing Understanding Pharmacoepidemiology you will have a better understanding of how to evaluate the associations between medication utilization and outcomes. Each chapter includes these valuable learning aids: A list of learning objectives Case studies or examples Discussion questions Tables and Figures You will also find a glossary of important words and terms. The content you need to understand the concepts and methods of pharmacoepidemiology: Introduction to Pharmacoepidemiology: Principles of Epidemiology Applied to the Study of Medication Use, Study Designs in Pharmacoepidemiology: Using Secondary Data in Pharmacoepidemiology; Biostatistics and Pharmacoepidemiology: Other Methodological Issues; Evaluation of Pharmacoepidemiology Literature; Medication Utilization Patterns; Medication Safety and Pharmacovigilance; and FDA Perspectives on Post-market Drug Safety.


Mann's Pharmacovigilance

Mann's Pharmacovigilance
Author: Elizabeth B. Andrews
Publisher: John Wiley & Sons
Total Pages: 878
Release: 2014-06-23
Genre: Medical
ISBN: 0470671041

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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.


Databases for Pharmacoepidemiological Research

Databases for Pharmacoepidemiological Research
Author: Miriam Sturkenboom
Publisher: Springer Nature
Total Pages: 276
Release: 2021-01-12
Genre: Medical
ISBN: 3030514552

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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

An Introduction to Pharmacovigilance
Author: Patrick Waller
Publisher: John Wiley & Sons
Total Pages: 194
Release: 2017-05-01
Genre: Medical
ISBN: 1119289742

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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.


Pharmacovigilance and Pharmacoepidemiology: Public Health and Safety

Pharmacovigilance and Pharmacoepidemiology: Public Health and Safety
Author: Thierry Trenque
Publisher: Frontiers Media SA
Total Pages: 190
Release: 2024-06-24
Genre: Science
ISBN: 2832550711

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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 and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance
Author: Pascale Tubert-Bitter
Publisher: Iste Press - Elsevier
Total Pages: 100
Release: 2019-03
Genre: Medical
ISBN: 9781785481611

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Pharmacoepidemiology and Pharmacovigilance provides understanding of up-to-date statistical methods applied to drug safety assessment from observational data. Postmarketing drug safety raises challenging methodological issues. Covers phamacovigilance using spontaneous reporting databases Explores statistical methods applied to drug safety assessment Features observational studies and provides understanding of up-to-date statistical methods.