Stephens Detection And Evaluation Of Adverse Drug Reactions

Author : John Talbot,Jeffrey K. Aronson
Publisher : John Wiley & Sons
Page : 751 pages
File Size : 54,9 Mb
Release : 2011-12-19
Category : Medical
ISBN : 9780470986349

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Stephens' Detection and Evaluation of Adverse Drug Reactions by John Talbot,Jeffrey K. Aronson Pdf

Written with practitioners in mind, this new edition of Stephen’s Detection of Adverse Drug Reactions: Principle and Practice continues to be one of the corner stones of the pharmaceutical medicine list. The classic text covers the issues and problems involved in the detection of adverse drug reactions (ADRs) throughout the life cycle of a medicine from animal studies through to clinical trials, its introduction to the market, followed by wide clinical use, and eventual decline in use or withdrawal. The sixth edition is completely revised and updated including five new chapters on pharmacogenomics, ADRs with herbal medicines, safety of medical devices, safety issues with oncology drugs, and economic aspects of ADRs. All tables and web information needed in order to practice are included to make this sixth edition a complete primer for the new practitioner and a reference for the more experienced.

Author : John Talbot,Patrick Waller
Publisher : John Wiley & Sons
Page : 776 pages
File Size : 42,8 Mb
Release : 2004-03-08
Category : Medical
ISBN : 047084552X

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Stephens' Detection of New Adverse Drug Reactions by John Talbot,Patrick Waller Pdf

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 : M. D. B. Stephens,J. C. C. Talbot
Publisher : Springer
Page : 269 pages
File Size : 45,5 Mb
Release : 1985-06-18
Category : Medical
ISBN : 9781349072507

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The Detection of New Adverse Drug Reactions by M. D. B. Stephens,J. C. C. Talbot Pdf

Author : M. D. B. Stephens
Publisher : Van Nostrand Reinhold Company
Page : 424 pages
File Size : 53,8 Mb
Release : 1993
Category : Drugs
ISBN : UOM:39015032917356

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Detection of New Adverse Drug Reactions by M. D. B. Stephens Pdf

This book examines the drug information cycle within pharmaceutical companies and assesses existing methods of collection, storage and processing of adverse event data and outlines ways of improving the drug information cycle. It is the only reference covering the entire field of pharmacovigilance.

Author : M. D. B. Stephens,J. C. C. Talbot,Philip Routledge
Publisher : Stockton Press
Page : 566 pages
File Size : 45,5 Mb
Release : 1998
Category : Drugs
ISBN : UOM:39015049974804

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Detection of New Adverse Drug Reactions by M. D. B. Stephens,J. C. C. Talbot,Philip Routledge Pdf

This book examines the drug information cycle within pharmaceutical companies and assesses existing methods of collection, storage and processing of adverse event data and outlines ways of improving the drug information cycle. It is the only reference covering the entire field of pharmacovigilance.

Author : Christian Bénichou
Publisher : John Wiley & Sons
Page : 328 pages
File Size : 48,7 Mb
Release : 1995-01-09
Category : Medical
ISBN : 0471942111

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Adverse Drug Reactions by Christian Bénichou Pdf

Reviews the biochemical and physiological abnormalities in each of the body's organ systems, enabling investigators to decide if the problem is of drug-induced origin. Much of the material is presented as a series of observations with accompanying questions which should be addressed in order to make an accurate diagnosis. Includes useful flow charts for the management of adverse drug events and examples of specific report forms.

Author : Patrick Waller,Mira Harrison-Woolrych
Publisher : John Wiley & Sons
Page : 192 pages
File Size : 54,7 Mb
Release : 2017-02-14
Category : Medical
ISBN : 9781119289784

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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.

Author : Elizabeth B. Andrews,Nicholas Moore
Publisher : John Wiley & Sons
Page : 878 pages
File Size : 46,6 Mb
Release : 2014-03-24
Category : Medical
ISBN : 9781118820148

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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.

Author : Zbigniew Bańkowski,John F. Dunne
Publisher : World Health Organization
Page : 214 pages
File Size : 40,5 Mb
Release : 1994
Category : Drug monitoring
ISBN : UCAL:B4767456

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Drug Surveillance by Zbigniew Bańkowski,John F. Dunne Pdf

Records the proceedings of an international conference convened to consider mechanisms for improving international cooperation in the surveillance of drug safety and the reporting of adverse reactions. Attended by close to 200 representatives of regulatory authorities and the pharmaceutical industry as well as clinical pharmacologists, the conference aimed to identify the strengths and weaknesses of existing mechanisms for international cooperation and to propose improvements for the future.

Author : World Health Organization
Publisher : Unknown
Page : 18 pages
File Size : 42,7 Mb
Release : 2004-01-01
Category : Drug monitoring
ISBN : 9241592214

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WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems by World Health Organization Pdf

Safety is a fundamental principle in the privision of herbal medicines and herbal products for health care and a critical component of quality control. These guidelines provide practical technical guidance for monitoring the safety of herbal medicines with pharmacovigilance systems.

Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Publisher : John Wiley & Sons
Page : 1220 pages
File Size : 45,7 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.

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Publisher : National Academies Press
Page : 292 pages
File Size : 53,7 Mb
Release : 2012-07-30
Category : Medical
ISBN : 9780309218160

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Ethical and Scientific Issues in Studying the Safety of Approved Drugs by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs Pdf

An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.

Author : Kevin Woodward
Publisher : John Wiley & Sons
Page : 776 pages
File Size : 41,8 Mb
Release : 2009-11-24
Category : Medical
ISBN : 144432294X

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Veterinary Pharmacovigilance by Kevin Woodward Pdf

Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert with over 20 years of experience in the field, it draws together the expertise of authors from around the world.

Author : Anonim
Publisher : Academic Press
Page : 288 pages
File Size : 41,5 Mb
Release : 2019-07-13
Category : Medical
ISBN : 9780128173176

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Drug-Induced Liver Injury by Anonim Pdf

Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. Includes the authority and expertise of leading contributors in pharmacology Presents the latest release in the Advances in Pharmacology series

Author : Justina Orleans-Lindsay
Publisher : John Wiley & Sons
Page : 182 pages
File Size : 45,9 Mb
Release : 2012-06-22
Category : Medical
ISBN : 9781118302064

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Pharmacovigilance Medical Writing by Justina Orleans-Lindsay Pdf

Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.