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Gad, S. C. Drug Safety Evaluation, 1007 pp. Wiley Interscience, New York, 2002. $170.00. ISBN 0-471-40727-5.

Drug Safety Evaluation is a single author text that attempts to provide an "all inclusive practical guide" to both nonclinical and clinical aspects of drug safety. The book is organized into 22 chapters and four appendices. Despite the more comprehensive title, the true focus of the book is non-clinical safety assessment in the development of pharmaceuticals. As such, the primary audience appears to be scientists engaged in nonclinical safety assessment.

After introductory chapters that review the various phases of drug development and the regulation of the pharmaceutical industry, 16 chapters cover various aspects of non-clinical safety assessment. In addition to the standard types of toxicity studies, chapters are devoted to evaluation of inhaled drugs, special concerns for biotechnology products, use of in vitro techniques, and the role of pharmacokinetics in toxicity studies. These chapters are generally well written, extensively referenced, and provide useful information. Tables are used extensively to summarize key aspects of regulatory guidance; however, occasional discrepancies were noted when similar material was contained in more than one table. For example, to support clinical trials of up to 2 weeks, one table indicates 2-week animal studies would be required, whereas another table indicates 4-week animal studies are needed. In addition, it is occasionally not clear when the information provided is a regulatory requirement versus a practical recommendation of the author. Another limitation is that although the author acknowledges that clinical and morphologic pathology data are among the most important data derived in nonclinical drug safety evaluation, only a few pages of this large text are devoted to this topic.

The author devotes only two chapters to clinical aspects of drug safety evaluation and monitoring. Although these chapters provide a reasonable summary that may help summarize this field for toxicologists and toxicologic pathologists, the information is much more superficial than that provided in the nonclinical section and neglects important emerging aspects of risk management plans, risk communication, and pharmacovigilance. The book concludes with a chapter on statistical analysis that provides a useful perspective on challenges unique to toxicity studies.

For toxicologic pathologists, this book is most useful as a reference book in a departmental library. The book does have utility for pathologists by providing an overview of areas of regulatory toxicology that are not part of formal pathology training. For toxicologists, the book would have benefited from additional information on the collection and interpretation of clinical and morphologic pathology data in toxicity studies. Individuals involved in clinical aspects of drug safety evaluation will likely be disappointed given the nonclinical focus of the book.

Dr. J. L. Vahle

Lilly Research Laboratories
Greenfield, IN

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