Abstract
The title of this book suggests that the authors' intention was to present an overview of the drug development process. Given the brevity of the book, a concise yet thorough treatment of this subject, which encompasses an entire industry, would be a challenging task. Nevertheless, such an overview would be a useful primer and reference for anyone working in the drug development field, including pathologists and particularly those new to the business or those wishing to gain a better understanding of the subject. Unfortunately, the authors generally fall short of this goal. Although the table of contents presents a logical outline on drug development, the actual text tends to be a stream-of-consciousness discourse on a wide variety of disjointed topics, from the authors' personal philosophies on health and happiness to Kampo (Japanese herbal) medicines. A sizeable portion of the text appears to be devoted to the authors' individual niche research interests rather than topics of broad interest to readers wishing to learn about drug development.
When the authors do tackle relevant topics, their treatment is fairly superficial and, in a few cases, inaccurate or out of date. The authors focus heavily on biotechnology products (for instance, nearly 10 pages are devoted to pondering specialized vaccine topics such as deoxyribonucleic acid and edible vaccines). Although these products are gaining in importance, the vast majority of effort within the industry is still concerned with small-molecule development, a topic on which there is disappointingly scant information presented in this book. Generally, and not surprisingly, given the authors' background and expertise, there is more emphasis placed on aspects of drug metabolism than on toxicology and pathology. Although there is a reasonable attempt by the authors to outline the regulatory process, even here they spend far too much ink on relatively minor topics. For instance, there is more space devoted to perspectives on drug approval in Taiwan than in the European Union, a perplexing priority, given the relative size of these respective markets.
Overall, this book is unlikely to be of great value to most readers. Although there are some interesting perspectives and trivia presented on unusual aspects of drug discovery and development, experienced readers will find little new information and naive readers will find it necessary to look elsewhere for critical details on the topics that represent the most salient aspects of the drug development process.