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.