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Doody's Review ServiceReviewer: Eric Goll, PharmD (University of Illinois at Chicago College of Pharmacy)
Description: This compilation of topics is designed expressly to challenge current approaches to the drug development process. Experts contributed chapters representing the many disciplines involved in drug development. The chapter topics include the evolution of drug discovery and development, impact of liability and cost containment, pharmaceutical issues, drug design, pharmacokinetics, clinical pharmacology, management (use of clinical research organizations), and regulatory affairs. The stated objective of the editors and chapter authors is to increase the reader's awareness of the challenges of drug development and present alternatives that might help improve what is considered an inefficient process.
Purpose: Current pressures of cost containment on the pharmaceutical industry has made drug development a timely and important topic. The book does provoke the reader's awareness when discussing the challenges and opportunities facing the drug development process.
Audience: The contributors represent the specialties of clinical pathology, pharmacology, and research. A majority of the contributors are associated with a pharmaceutical corporation. In view of the complexity of the book and background of the authors, the book is intended primarily for use by pharmaceutical scientists or pharmacologists.
Features: All three editors have strong achievements in research and the drug development process. They efficiently utilize a variety of tables, flow charts, bar graphs, and diagrams to illustrate the book. The book is well referenced.
Assessment: This publication provides the serious reader with a thorough description of the drug development process, emphasizing alternatives for increasing efficiency and containing costs. The book seemed somewhat biased to an industry perspective. It would have been of benefit to include a chapter on the FDA's viewpoint. Due to the book's complex nature, it will have a limited audience. However, individuals working in regulatory, academic, and industrial environments will find the book stimulating.