Author: M. D. B. Stephens
Publisher: Springer
ISBN: 1349072508
Category : Medical
Languages : en
Pages : 269

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Book Description

Author: John Talbot
Publisher: John Wiley & Sons
ISBN: 0470092653
Category : Medical
Languages : en
Pages : 762

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Book Description
A key text for all those involved in pharmacovigilance. Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues. Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia. The fifth edition of this classic reference work includes new chapters on: vaccine safety surveillance managing drug safety issues with marketed products operational aspects of drug safety function safety of biotechnology products future of pharmacovigilance Reviews of previous editions: "This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read." —Commended by the 1999 BMA Medical Book Competition "For anyone entering the field of adverse reaction monitoring one could not wish for a better primer" —International Journal of Risk and Safety in Medicine

Author: John Talbot
Publisher: John Wiley & Sons
ISBN: 1119952107
Category : Medical
Languages : en
Pages : 751

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Book Description
The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS "...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal

Author: Elizabeth B. Andrews
Publisher: John Wiley & Sons
ISBN: 1118820142
Category : Medical
Languages : en
Pages : 878

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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.

Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: Cioms
ISBN: 9789290360827
Category : Drug monitoring
Languages : en
Pages : 0

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Book Description
In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.

Author: Patrick Waller
Publisher: John Wiley & Sons
ISBN: 1119289742
Category : Medical
Languages : en
Pages : 194

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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.

Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385

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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Author: Brian L. Strom
Publisher: John Wiley & Sons
ISBN: 1118708008
Category : Medical
Languages : en
Pages : 756

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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

Author: World Health Organization
Publisher:
ISBN: 9789241590150
Category : Drug monitoring
Languages : en
Pages : 48

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Book Description
The purpose of this document is to present the case for the importance of pharmacovigilance, to record its growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health.

Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Medical
Languages : en
Pages : 656

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Book Description
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. - Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues - Describes current achievements of drug safety practice in developing countries - Addresses the challenges of drug safety in developing countries - Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety