Pharmacoepidemiology And Pharmacovigilance

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Pharmacoepidemiology and Pharmacovigilance

Sabrina Nour,Gilles Plourde
Pharmacoepidemiology and Pharmacovigilance Book PDF

Author : Sabrina Nour,Gilles Plourde
Publisher : Academic Press
Page : 144 pages
File Size : 44,8 Mb
Release : 2018-10-17
Category : Medical
ISBN : 9780128163818

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Pharmacoepidemiology and Pharmacovigilance by Sabrina Nour,Gilles Plourde Pdf

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

Brian L. Strom
Pharmacoepidemiology Book PDF

Author : Brian L. Strom
Publisher : John Wiley & Sons
Page : 912 pages
File Size : 52,9 Mb
Release : 2006-01-04
Category : Medical
ISBN : 9780470866832

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Pharmacoepidemiology by Brian L. Strom Pdf

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

Brian L. Strom,Stephen E. Kimmel
Textbook of Pharmacoepidemiology Book PDF

Author : Brian L. Strom,Stephen E. Kimmel
Publisher : John Wiley & Sons
Page : 756 pages
File Size : 47,7 Mb
Release : 2013-05-13
Category : Medical
ISBN : 9781118708002

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Textbook of Pharmacoepidemiology by Brian L. Strom,Stephen E. Kimmel Pdf

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

Maria Teresa Herdeiro,Fátima Roque,Tânia Magalhães Silva,Adolfo Figueiras
New Insights into the Future of Pharmacoepidemiology and Drug Safety Book PDF

Author : Maria Teresa Herdeiro,Fátima Roque,Tânia Magalhães Silva,Adolfo Figueiras
Publisher : BoD – Books on Demand
Page : 202 pages
File Size : 44,6 Mb
Release : 2021-10-13
Category : Medical
ISBN : 9781839685965

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New Insights into the Future of Pharmacoepidemiology and Drug Safety by Maria Teresa Herdeiro,Fátima Roque,Tânia Magalhães Silva,Adolfo Figueiras Pdf

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.

Mann's Pharmacovigilance

Elizabeth B. Andrews,Nicholas Moore
Mann s Pharmacovigilance Book PDF

Author : Elizabeth B. Andrews,Nicholas Moore
Publisher : John Wiley & Sons
Page : 878 pages
File Size : 49,5 Mb
Release : 2014-06-23
Category : Medical
ISBN : 9780470671047

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Mann's Pharmacovigilance by Elizabeth B. Andrews,Nicholas Moore Pdf

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.

Understanding Pharmacoepidemiology

Yi Yang,Donna West-Strum
Understanding Pharmacoepidemiology Book PDF

Author : Yi Yang,Donna West-Strum
Publisher : McGraw Hill Professional
Page : 208 pages
File Size : 48,5 Mb
Release : 2010-12-31
Category : Medical
ISBN : 9780071766678

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Understanding Pharmacoepidemiology by Yi Yang,Donna West-Strum Pdf

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.

Databases for Pharmacoepidemiological Research

Miriam Sturkenboom,Tania Schink
Databases for Pharmacoepidemiological Research Book PDF

Author : Miriam Sturkenboom,Tania Schink
Publisher : Springer Nature
Page : 276 pages
File Size : 48,5 Mb
Release : 2021-01-12
Category : Medical
ISBN : 9783030514556

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Databases for Pharmacoepidemiological Research by Miriam Sturkenboom,Tania Schink Pdf

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

Patrick Waller,Mira Harrison-Woolrych
An Introduction to Pharmacovigilance Book PDF

Author : Patrick Waller,Mira Harrison-Woolrych
Publisher : John Wiley & Sons
Page : 194 pages
File Size : 48,8 Mb
Release : 2017-05-01
Category : Medical
ISBN : 9781119289746

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An Introduction to Pharmacovigilance by Patrick Waller,Mira Harrison-Woolrych Pdf

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.

Pharmacoepidemiology and Pharmacovigilance

Pascale Tubert-Bitter,Ismail Ahmed,Sylvie Escolano
Pharmacoepidemiology and Pharmacovigilance Book PDF

Author : Pascale Tubert-Bitter,Ismail Ahmed,Sylvie Escolano
Publisher : Iste Press - Elsevier
Page : 100 pages
File Size : 47,6 Mb
Release : 2019-03
Category : Medical
ISBN : 1785481614

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Pharmacoepidemiology and Pharmacovigilance by Pascale Tubert-Bitter,Ismail Ahmed,Sylvie Escolano Pdf

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.

Practical Drug Safety from A to Z

Barton Cobert,Pierre Biron
Practical Drug Safety from A to Z Book PDF

Author : Barton Cobert,Pierre Biron
Publisher : Jones & Bartlett Publishers
Page : 406 pages
File Size : 42,6 Mb
Release : 2009-10-06
Category : Medical
ISBN : 9780763745271

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Practical Drug Safety from A to Z by Barton Cobert,Pierre Biron Pdf

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.

Pharmacovigilance: A Practical Approach

Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
Pharmacovigilance A Practical Approach Book PDF

Author : Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
Publisher : Elsevier Health Sciences
Page : 228 pages
File Size : 40,6 Mb
Release : 2018-07-31
Category : Medical
ISBN : 9780323581172

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Pharmacovigilance: A Practical Approach by Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini Pdf

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

Barton Cobert,President Blcmd Associates LLC Westfield New Jersey Barton Cobert
Cobert s Manual of Drug Safety and Pharmacovigilance Book PDF

Author : Barton Cobert,President Blcmd Associates LLC Westfield New Jersey Barton Cobert
Publisher : Jones & Bartlett Publishers
Page : 431 pages
File Size : 44,5 Mb
Release : 2011-04
Category : Medical
ISBN : 9780763791605

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Cobert's Manual of Drug Safety and Pharmacovigilance by Barton Cobert,President Blcmd Associates LLC Westfield New Jersey Barton Cobert Pdf

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.

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

Cobert Barton,Gregory William,Thomas Jean-loup
Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition Book PDF

Author : Cobert Barton,Gregory William,Thomas Jean-loup
Publisher : World Scientific
Page : 524 pages
File Size : 46,9 Mb
Release : 2019-04-10
Category : Medical
ISBN : 9789813279162

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Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) by Cobert Barton,Gregory William,Thomas Jean-loup Pdf

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.

Post-Authorization Safety Studies of Medicinal Products

Ayad K. Ali,Abraham G. Hartzema
Post Authorization Safety Studies of Medicinal Products Book PDF

Author : Ayad K. Ali,Abraham G. Hartzema
Publisher : Academic Press
Page : 362 pages
File Size : 53,5 Mb
Release : 2018-06-27
Category : Medical
ISBN : 9780128092088

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Post-Authorization Safety Studies of Medicinal Products by Ayad K. Ali,Abraham G. Hartzema Pdf

Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approaches for causal interference from observational data. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. Readers will be able to effectively and efficiently design and interpret findings from post-authorization safety studies with the goal of improving the benefit-risk balance of a drug in order to optimize patient safety. Discusses all types of observational studies in post-marketing drug safety assessment, from spontaneous reporting systems, to pragmatic trials, with examples from real-world settings Presents various types of post-authorization safety studies Offers solutions to the common challenges in the design and conduct of these studies Highlights active surveillance programs, including common data models for rapid signal detection of drug safety issues

Pharmacoepidemiology

Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Pharmacoepidemiology Book PDF

Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Publisher : John Wiley & Sons
Page : 1220 pages
File Size : 51,6 Mb
Release : 2019-12-16
Category : Medical
ISBN : 9781119413417

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Pharmacoepidemiology by Brian L. Strom,Stephen E. Kimmel,Sean Hennessy Pdf

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.