This book is interesting, comprehensive, clearly written, and a straightforward guide to get you through preclinical drug development and testing. This is a hands‐on guide for pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all Federal Drug Administration (FDA) requirements before clinical trials may begin. If you follow the books step‐by‐step guidance you will be able to initiate and complete critical phases of preclinical drug development.
Each chapter of the book was written by one or more experts in the field covered by that chapter. Each offers a full exploration of the problems that might be encountered and their solutions. The contributors also write about the limitations of various methods and techniques used to determine the safety and efficacy of a drug during the preclinical stage. The contributors are involved in the many disciplines required to understand and perform preclinical toxicology screening and give the reader the tools and knowledge required for the application of an effective, multidisciplinary approach to testing.
The Handbook runs to 1,059 pages divided into 31 chapters. The editor, with more than 30 years experience working with pharmaceutical and biotechnology companies, carefully reviewed all chapters to ensure that each was thorough, accurate and clear. Among the key topics covered are: in vitro mammalian cytogenetics tests; phototoxicity; carcinogenicity studies; the pharmacogenomics of personalized medicine; bridging studies; toxicogenomics and toxicoproteomics.
Again, this is a hands‐on guide specifically for pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements. Unless a library serves such personnel, or unless it has enquiries from those curious about preclinical trials, this is not a handbook that will receive regular reference use.
