Beta-Lactam Antibiotics For Clinical Use. Clinical Pharmacology Series, Volume 4. Edited by Sherry F. Queener, J. Alan Webber, and Stephen W. Queener. Marcel Dekker: New York. 1986. xv + 673 pp. 15 x 23 cm. ISBN 0-8247-7386-1. $99.75.
Beta-Lactam Antibiotics For Clinical Use is a collection of sixteen chapters covering a broad range of topics on penicillins, cephalosporins, and other beta-lactam antibiotics. The chapters are divided into four main sections: “B-Lactam Antibiotics: General Considerations,” “Penicillins,” “Cephalosporins,” and “Novel Types of B-Lactam Antibiotics.” Although the book is long, it is well organized by chapter, and the index is good, making it relatively easy to find specific information. The first section covers a number of interesting topics on penicillins and cephalosporins. The first chapter on historical origins and the second on mode of action of beta-lactam antibiotics are particularly well done; they are concise and lay a sound foundation for the material that follows. The remainder of the section contains chapters on beta-lactam resistance, hospital resistance to beta-lactams, biosynthesis, manufacture of penicillins, and the pharmacology and pharmacokinetics of penicillins. Chapter seven, on the pharmacology and pharmacokinetics of penicillins, has a number of disconcerting typing errors. The title “Penicillins” is somewhat of a misnomer for the second section, since, in addition to a chapter on clinical applications of penicillins, it contains two chapters on the manufacture of cephalosporins and the pharmacology of cephalosporins. These chapters are also generally well written and up-to-date. The third section, on cephalosporins, includes chapters on the clinical use of cephalosporins, moxalactam, and cefoxitin and other cephamycins. The last‘chapter is somewhat disappointing since it gives only cursory attention to cephamycins other than cefoxitin. The final section covers new types of beta-lactams including imipenem, augmentin, and aztreonam and other monobactams. In reality the last chapter deals primarily with Squibb’s monobactam experience. Several of the chapters in sections three and four on individual agents come across as a selling effort, which seems out of place. Overall the book is well written with few errors, and the references cited include those through early 1984. While covering most recent clinical developments with beta-lactam antibiotics, the penem class is noticably absent. A particularly strong suit of t h e book is the many excellent tables throughout which make it easy to access the information presented. The organization by sections, the excellent tables, and reasonable index make this book a good reference source. This book should be a welcome addition to the library of any
856 1 Journal of Pharmaceutical Sciences Vol. 76, No. 10. October 1987
individual or company engaged in the clinical development of new beta-lactam antibiotics. John G. Stam Pfizer Central Research Groton, CT 06340
New Drug Development: A Regulatory Overview. Edited by Mark P. Mathieu and William J. Murphy I l l . OMEC International, Inc., Washington, DC. 1987. 202 p. 15 x 23 cm.
$75.00. The title of the book is somewhat a misnomer, as the book covers only t h e new drug approval process of the Federal Food, Drug, and Cosmetic Act. The authors have excluded the regulatory systems applicable to such important classes of drugs as biologics, antibiotics, and animal drugs. The book is divided into two sections. Section I is devoted primarily to a description of the investigational and t h e new drug approval processes and the editors seem at their best in Section I when discussing these processes. Section I1 contains various subjects which the authors describe as intended to aid the reader’s understanding of the new drug approval process and the responsibilities and opportunities facing those firms t h a t obtain FDA approval for a new drug. This second section covers a number of diverse topics such as drug listing, good manufacturing practices, and even a brief history of the Federal Food, Drug, and Cosmetic Act. O n the other hand, some statements are so basic t h a t one often gets the impression t h a t one is reading a n elementary, government-prepared piece designed for t h e public. The most glaring deficiency of the book is its failure to provide citations to the applicable regulations and governing sections of t h e Food, Drug, and Cosmetic Act so t h a t the interested reader or one involved in t h e NDA process can look up the actual requirement or obtain more detailed information. On the plus side, t h e contents are logically subdivided, and easy to follow and read. As its title indicates, the book is a n overview, and i t should be of value to the novice or one unfamiliar with the United States new drug approval process and who has a need to place the process in perspective. Joseph G. Valentino United States Pharmacopeial Convention, Inc. Rockville, MD 20852
OO22-3~9/87/1000-0856$01 .OO/O 0 1987, American Pharmaceutical Association