Abstract

A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications.

By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing.

• Chapters written by world-renowned contributors who are experts in their fields
• Includes the latest research in preclinical drug testing and international guidelines
• Covers preclinical toxicology in small molecules and biologics in one single source

"…a wide-ranging overview of various areas of toxicology, covering a relatively novel selection of subject areas that are not normally seen together...This book is reasonably priced…it would be a good addition to a toxicologist’s bookshelf or an Institution’s library."--BTS Newsletter, Summer 2013 "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."--Journal of the American Veterinary Medicine Association, December 15, 2013 "The first new toxicology text to address both small and large molecules within the drug development process with contributions from leading scientists from around the globe is now available. Published by Elsevier, A Comprehensive Guide to Toxicology in Preclinical Drug Development covers the entire process of preclinical drug testing, beginning with investigative toxicology and includes the evaluation of the toxicologic and pharmacologic effects of new chemical entities, as well as in vitro and in vivo laboratory animal testing."--Drug Discovery Online, March 29, 2013 "Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology…By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing."--VeterinaryWorld.org, April 17, 2013