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Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice
     

Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice

by John Talbot, Jeffrey K. Aronson
 

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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

Overview

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

Editorial Reviews

Doody's Review Service
Reviewer: Thomas L. Pazdernik, PhD (University of Kansas Medical Center)
Description: This is an updated and expanded authoritative resource on drug safety valuable to all who work in pharmacovigilance.
Purpose: The book was initiated by Myles Stephens, a giant in the field of pharmacovigilance communications. He has selected John Talbot and Jeff Aronson to carry on the expansion and updating of this classic reference on drug safety. They have done a marvelous job with this sixth edition.
Audience: This is an excellent reference source for anyone who works in pharmacovigilance or has an interest in adverse drug reactions, including regulatory authorities, pharmaceutical companies, and academicians.
Features: It reviews all aspects of adverse drug reactions throughout the life cycle of a medicinal agent. The focus is on both basic toxicology and clinical trials, keeping in mind the importance of communication of information related to pharmacovigilance, risk management, and legal and regulatory requirements. The safety of biotherapeutics and vaccines are also covered in this edition. Moreover, new chapters have been added on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. Appendix 1 provides websites relevant to pharmacovigilance along with an analysis of their contents and Appendix 2 provides guidelines and a checklist for reporting adverse drug reactions anecdotally in journals. The book is well written and extensively referenced.
Assessment: This remains a classic authoritative resource for anyone working in the area of pharmacovigilance. Moreover, it brings to this topic advances in toxicological sciences as well as in the handling of bioinformation. A vast array of experts in the science of pharmacovigilance contribute to this book, but the editors have maintained a clarity of presentation, keeping in mind that communication is a key factor in pharmacovigilance.

Product Details

ISBN-13:
9781119952107
Publisher:
Wiley
Publication date:
10/28/2011
Sold by:
Barnes & Noble
Format:
NOOK Book
Pages:
648
File size:
4 MB

What People are Saying About This

From the Publisher
“A vast array of experts in the science of pharmacovigilance contribute to this book, but the editors have maintained a clarity of presentation, keeping in mind that communication is a key factor in pharmacovigilance.” (Doody’s, 27 July 2012)

Meet the Author

John Talbot, Senior Lecturer, University of Hertfordshire, UK. Formerly Director, Global Drug Safety, AstraZeneca R&D Charnwood, Loughborough, Leicestershire, UK

Jeffrey Aronson, Reader in Clinical Pharmacology, University of Oxford, Oxford, UK and President Emeritus of the British Pharmacological Society

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