Manual of Drug Safety and Pharmacovigilance
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Paul Stang, PkD Johnson &Johnson Pharmaceutical Research and Development, Titusville. New Jersey
Key Words Drug safety: Pharmacovigilance Correspondence Address Paul Stang, Johnson 6. JohnsonPharmaceutical Research and Development, 1125 Trenton-Harbourion Road.PO Box 200, Titusville. NJ 08560 (e-mail: [email protected].)
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Book Review
Cobert, Barton: MANUAL OFDRUG SAFETY AND PHARMACOVIGZLANCE. Sudbury, Massachusetts: Jonesand Bartlett Publishers: 2007. (Includes CD-ROM) Few would argue that drug safety, long the internal pessimistic denizen of the pharmaceutical company, has emerged as a critical public health function. Only those who have survived the tortured path of the safety group have the necessary combination of insight and expertise that allows them to interpret this changing political and regulatory landscape while still maintaining a scientific approach to their work. Unlike many other corporate functions, the role of this department is to effectively and efficiently capture, categorize, report, and summarize disparate individual reports of adverse events in those who have taken the company's product, somehow striking a balance between the quality of the data, the extent of use, and the objectivity necessary to convey either comforting or disturbing news to the corporate management. It is a complicated livelihood, as many of the events seem unrelated to drug exposure and are poorly documented. The field of spontaneous reporting more likely resembles forensic cold-case studies with precious few threads of evidence than the "high" science of clinical and pharmacologic medicine.
There is no shortage of books on the subject, with most resembling texts and academic discourse (which clearly have a role). Cobert's book attempts to fill a palpable void: a crisp, utilitarian guide that helps acclimate the reader to a highly regulated, compliance-driven process whose penultimate contributions are shreds of data on which the lives of many may depend. It is rarefied air indeed. There are several strengths to Cobert's approach. First, the book is organized into 50 bitesized chapters, each averaging five pages, that are relatively independent of each other. The content of the book is contained in the accompanying CD, which facilitates rapid searching (complete with direct links to relevant Internet sites). This allows the reader the luxury of seeking only the content required without having to sequentially labor through preceding text. Although this resembles the encyclopedia approach, the content of each chapter conveys the necessary depth and points the reader to additional sources for any additional details. Its breadth is somewhat encyclopedic while its depth is a succinct study guide complete with copious examples, references, and a brief FAQ section at the end of each chapter. Separate chapters and subchapters blissfully address critical regulatory issues and requirements, harmonization efforts, and documents in a bulleted and well-hydrated prose.
Drug Information Journal. Vd.41, pp. 429-430,2007 0092-
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