Table of Contents

Adverse drug reactions : history, terminology, classification, causality, frequency, preventability / Jeffrey K. Aronson.
Pharmacogenetics of adverse drug reactions / Sudeep P. Pushpakom & Munir Pirmohamed.
Toxicology and adverse drug reactions / D.J. Snodin & A. Suitters.
Clinical trials' collecting safety data and establishing the adverse drug reactions profile / John Talbot, Marianne Keisu & Lars Stohle.
Clinical laboratory safety data / Alan Craig.
Statistics : analysis and presentation of safety data / Stephen J.W. Evans & Dorothea Nitsch.
Proactive pharmacovigilance and risk management / June Raine ... [et al.].
Regulatory aspects of pharmacovigilance / K.L. Strutt & B.D.C. Arnold.
Legal aspects of pharmacovigilance in the European Union / Christine H. Bendall.
Dictionaries and coding in pharmacovigilance / E.G. Brown & J.E. Harrison.
Adverse drug reactions : societal considerations / Nicky Britten.
Safety of biotherapeutics / Andrew Erdman, James Nickas & Benton Brown.
Vaccine safety surveillance / E. Miller & J. Stowe.
The adverse effects of drugs used in oncology / Anne Kehely.
Adverse drug reactions and pharmacovigilance of herbal medicines / Joanne Barnes.
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.