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Pharmacoepidemiology And Pharmacovigilance

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Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance Book
Author : Sabrina Nour,Gilles Plourde
Publisher : Academic Press
Release : 2018-10-17
ISBN : 012816381X
Language : En, Es, Fr & De

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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

Mann s Pharmacovigilance

Mann s Pharmacovigilance Book
Author : Elizabeth B. Andrews,Nicholas Moore
Publisher : John Wiley & Sons
Release : 2014-03-24
ISBN : 1118820142
Language : En, Es, Fr & De

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Book Description :

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

Pharmacoepidemiology Book
Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Publisher : John Wiley & Sons
Release : 2019-10-18
ISBN : 1119413370
Language : En, Es, Fr & De

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Book Description :

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.

Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance Book
Author : Gilles Plourde,Sabrina Nour
Publisher : Academic Press
Release : 2018-10
ISBN : 9780128161838
Language : En, Es, Fr & De

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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

Databases for Pharmacoepidemiological Research

Databases for Pharmacoepidemiological Research Book
Author : Miriam Sturkenboom,Tania Schink
Publisher : Springer Nature
Release : 2021-01-12
ISBN : 3030514552
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Patrick Waller,Mira Harrison-Woolrych
Publisher : John Wiley & Sons
Release : 2017-02-14
ISBN : 1119289785
Language : En, Es, Fr & De

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Book Description :

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

Pharmacoepidemiology Book
Author : Brian L. Strom
Publisher : John Wiley & Sons
Release : 2006-01-04
ISBN : 0470866837
Language : En, Es, Fr & De

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Book Description :

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

Post Authorization Safety Studies of Medicinal Products

Post Authorization Safety Studies of Medicinal Products Book
Author : Ayad K. Ali,Abraham G. Hartzema
Publisher : Academic Press
Release : 2018-06-27
ISBN : 0128092084
Language : En, Es, Fr & De

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Book Description :

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

Clinical Pharmacy Education Practice and Research

Clinical Pharmacy Education  Practice and Research Book
Author : Dixon Thomas
Publisher : Elsevier
Release : 2018-11-23
ISBN : 0128142774
Language : En, Es, Fr & De

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Book Description :

Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. Covers the core information needed for pharmacy practice courses Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge Designed for educational settings, but also useful as a refresher for advanced students and researchers

New Insights into the Future of Pharmacoepidemiology and Drug Safety

New Insights into the Future of Pharmacoepidemiology and Drug Safety Book
Author : Maria Teresa Herdeiro,Fátima Roque,Tânia Magalhães Silva,Adolfo Figueiras
Publisher : BoD – Books on Demand
Release : 2021-10-13
ISBN : 1839685964
Language : En, Es, Fr & De

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Book Description :

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.

Textbook of Pharmacoepidemiology

Textbook of Pharmacoepidemiology Book
Author : Brian L. Strom,Stephen E. Kimmel
Publisher : John Wiley & Sons
Release : 2013-05-13
ISBN : 1118708008
Language : En, Es, Fr & De

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Book Description :

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

Drug Utilization Research

Drug Utilization Research Book
Author : Monique Elseviers,Björn Wettermark,Anna Birna Almarsdóttir,Morten Andersen,Ria Benko,Marion Bennie,Irene Eriksson,Brian Godman,Janet Krska,Elisabetta Poluzzi,Kstja Taxis,Vera Vlahovic-Palcevski,Robert Vander Stichele
Publisher : John Wiley & Sons
Release : 2016-05-31
ISBN : 1118949781
Language : En, Es, Fr & De

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Book Description :

Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked mainly to the broader field of pharmacoepidemiology, but also to health outcomes research, pharmacovigilance and health economics. Drug Utilization Research is a unique, practical guide to the assessment and evaluation of prescribing practices and to interventions to improve the use of medicines in populations. Edited by an international expert team from the International Society for Pharmacoepidemiology (ISPE), DUR is the only title to cover both the methodology and applications of drug utilization research and covers areas such as health policy, specific populations, therapeutics and adherence.

Pharmacovigilance

Pharmacovigilance Book
Author : Ronald D. Mann,Elizabeth B. Andrews
Publisher : John Wiley & Sons
Release : 2007-02-06
ISBN : 0470059222
Language : En, Es, Fr & De

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Book Description :

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

Understanding Pharmacoepidemiology

Understanding Pharmacoepidemiology Book
Author : Yi Yang,Donna West-Strum
Publisher : McGraw Hill Professional
Release : 2010-12-31
ISBN : 9780071766678
Language : En, Es, Fr & De

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Book Description :

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.

Pharmacovigilance

Pharmacovigilance Book
Author : I. Ralph Edwards,Marie Lindquist
Publisher : Springer
Release : 2016-10-27
ISBN : 3319404008
Language : En, Es, Fr & De

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Book Description :

Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice. Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus more on science and practices that support health professionals and patients in day-to-day care situations. To achieve this, a dynamic and sustainable development of vigilance must take precedence over the current excessive preoccupations with data processing and regulations; all aspects of medicines use and their effects need to be considered; and all stakeholders must be involved and engaged in an open and constructive debate. The work is essential reading for anyone who has an interest in safer use of medicines. It is intended to be equally challenging and rewarding, and sets out to stimulate a continuous debate on how pharmacovigilance can better meet the needs of health professionals and patients to achieve the aim of wise therapeutic decision making.

Global Pharmaceutical Policy

Global Pharmaceutical Policy Book
Author : Zaheer-Ud-Din Babar
Publisher : Springer Nature
Release : 2020-06-15
ISBN : 9811527245
Language : En, Es, Fr & De

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Book Description :

Medicines are vital in improving patient health outcomes and pharmaceutical policy is a fundamental component of any health system. However, the global pharmaceutical policy is ever-evolving and data and quality ‘research-based information’ in this field are scarce. This book fills this gap and provides up-to-date empirical information and evidence-based synthesis. It focuses on pertinent key issues in global pharmaceutical policy including medicines safety, generic medicines, pharmaceutical supply chain, medicines financing, access and affordability of medicines, rational use of medicines, pharmacy health services research and access to vaccines and biological products. Featuring policy case studies from varied countries such as Mexico, Russia, China, Kyrgyzstan, and Pakistan, this book comprises a valuable and comprehensive resource for students, funders, policymakers, academics, and researchers interested in this field.

Pharmacy Practice in Developing Countries

Pharmacy Practice in Developing Countries Book
Author : Ahmed Fathelrahman,Mohamed Ibrahim,Albert Wertheimer
Publisher : Academic Press
Release : 2016-02-13
ISBN : 0128017112
Language : En, Es, Fr & De

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Book Description :

Pharmacy Practice in Developing Countries: Achievements and Challenges offers a detailed review of the history and development of pharmacy practice in developing countries across Africa, Asia, and South America. Pharmacy practice varies substantially from country to country due to variations in needs and expectations, culture, challenges, policy, regulations, available resources, and other factors. This book focuses on each country’s strengths and achievements, as well as areas of weakness, barriers to improvement and challenges. It sets out to establish a baseline for best practices, taking all of these factors into account and offering solutions and opportunities for the future. This book is a valuable resource for academics, researchers, practicing pharmacists, policy makers, and students involved in pharmacy practice worldwide as it provides lessons learned on a global scale and seeks to advance the pharmacy profession. Uses the latest research and statistics to document the history and development of pharmacy practice in developing countries Describes current practice across various pharmacy sectors to supply a valuable comparative analysis across countries in Africa, Asia, Europe, and South America Highlights areas of achievement, strengths, uniqueness, and future opportunities to provide a basis for learning and improvement Establishes a baseline for best practices and solutions

Textbook of Pharmacoepidemiology

Textbook of Pharmacoepidemiology Book
Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Publisher : John Wiley & Sons
Release : 2021-10-18
ISBN : 1119701074
Language : En, Es, Fr & De

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Book Description :

Pharmacoepidemiology originally arose from the union of the fields of clinical pharmacology and epidemiology. Pharmacoepidemiology studies the use of and the effects of medical products in large numbers of people and applies the methods of epidemiology to the content area of clinical pharmacology. This field represents the science underlying studies of the effects of medical products (such as drugs, biologicals, and devices) in real world use. Strom’s Textbook of Pharmacoepidemiology meets the increasing need for people to be trained in the field. Designed to meet the need of students, this textbook offers an approach that focuses on the core of the discipline, providing a focused educational resource for students. The book is designed for students at all levels: upper-level undergraduates, graduate students, post-doctoral fellows, and others who are learning the field. Case examples feature in most chapters, and all chapters include key points and a list of further reading. Fully revised and updated throughout, Textbook of Pharmacoepidemiology, 3rd edition is a useful introduction and resource for students of pharmacoepidemiology, both those enrolled in formal classes and those learning in “the real world,” who will respond to the challenges that they encounter.

Pharmacoepidemiology

Pharmacoepidemiology Book
Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Publisher : John Wiley & Sons
Release : 2019-10-23
ISBN : 1119413427
Language : En, Es, Fr & De

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Book Description :

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.

Mann s Pharmacovigilance

Mann s Pharmacovigilance Book
Author : Elizabeth B. Andrews,Nicholas Moore
Publisher : John Wiley & Sons
Release : 2014-06-23
ISBN : 0470671041
Language : En, Es, Fr & De

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Book Description :

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.