Book Reviews

Bacterial Toxins: Genetics, Cellular Biology and Practical Applications

Thomas Profit

234 pages. 2013. Caister Academic Press. ISBN 978-1-908230-28-7. Price $319.00.

Written by 20 experts and divided into 9 chapters, Bacterial Toxins: Genetics, Cellular Biology and Practical Applications meets the editor's stated goal of highlighting recent advances in toxin research, particularly those made by complete genome sequencing and protein crystallography. Although each chapter is comprehensive and provides a detailed review of recent findings on a given topic and could be a standalone resource, the chapters work well together when integrated into this book. The sections on Escherichia coli verotoxin, Helicobacter pylori CagA, and staphylococcal superantigen-like toxins, in particular, are written with researchers in mind. Although these chapters contain review sections that students and practitioners may find useful, they are followed by in-depth descriptions of toxin structure and the effects of toxins on cells at the protein level, which will likely be of interest only to microbiologists and cell biologists. Conversely, the chapters on Clostridium difficile toxin and the uses of botulinum toxin are more appropriate for a general audience.

Initial consultation of the table of contents could lead readers to wonder whether advances in the understanding of anthrax toxin and clostridial toxins aside from C difficile are discussed in this book. Although these toxins do not have specific chapters dedicated to them, they are discussed in some depth in chapter 3, titled Poor-forming Toxins. This book is not intended to be an exhaustive review of bacterial toxins, but anyone with a willingness to embrace an in-depth study of the material will find it to be a valuable review. As long as readers recognize the intended scope of the book, they will not be disappointed. The price of the book may make it best suited for library acquisition rather than individual purchase, but overall, it is worth reading.

Reviewed by Sara D. Lawhon, DVM, PhD, DACVM

Texas A&M University College Station, Tex

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Ali S. Faqi

885 pages. 2013. Elsevier. ISBN 978-0-12-387815-1. Price $199.95.

A crucial phase during drug development is the broad series of preclinical toxicological studies necessary for evaluating drug safety prior to the initiation of clinical studies in humans. Safety issues remain a leading factor for attrition during drug development, and most safety-related attrition occurs during preclinical toxicological testing. A Comprehensive Guide to Toxicology in Preclinical Drug Development is a detailed guide for toxicologists, regulatory scientists, and academics working in drug discovery, development, or regulatory sciences. The inclusion of the word comprehensive in the title is quite fitting because all topics regarding toxicology during drug development are expertly covered as are metatopics that, while important to the subject matter, one might expect to find in other references. The 36 chapters in this book include detailed discussions of both classical toxicology (pharmacokinetics and toxicokinetics; acute, subacute, and chronic toxicity testing; carcinogenicity testing; clinical and anatomic pathology; developmental and reproductive toxicology; and genetic toxicology) and emerging technologies (drug-abuse potential testing, imaging, predictive toxicology, carcinogenicity in genetically engineered animals, metabonomics, and toxicogenomics). Both small and large molecules are integrated into discussions, a first for such a comprehensive reference. Moreover, this book includes chapters dedicated to preclinical testing for specific drug classes (vaccines, oligonucleotides, monoclonal antibodies, and botanicals), indications (oncology and ocular), and special populations (pediatric). Chapters on regulatory toxicology regarding the role of the study director, preclinical monitoring, and biostatistics are also included. Additionally, there is a chapter on new drug regulations and approval in China, an important emerging drug market, and a chapter on virtual drug development of in-licensed pharmaceuticals, which will be of interest to entrepreneurs. These 2 metatopical chapters serve as good primers and provide readers with references that are solely dedicated to each topic. A specific strength of the book is the contributions made by an outstanding group of thought leaders, which provide readers with fresh approaches to the challenges of preclinical safety. Because of the knowledge-based experience conveyed by the authors, this book will likely become a go-to reference for those involved in the planning, execution, or oversight of drug development. From a veterinary perspective, the sole weakness of this comprehensive book is the absence of a specific chapter on animal health drug development. This book will be an important addition to the libraries of researchers in toxicology and related disciplines, and with its comprehensive approach to preclinical toxicology, it will be a key reference for any medical professional interested in drug development.

Terrence P. Clark, DVM, PhD, DACVCP

Nexcyon Pharmaceuticals Inc Madison, Wis