This new edition of Drug Safety Evaluation is a complete revision that also maintains the central objective of its predecessors, presenting an all-inclusive practical guide for those who are responsible for developing new drugs and ensuring the safety of an ever-expanding spectrum of therapeutics.  The many changes in the scope of products (small synthetic, large protein moieties and cells and tissues), harmonized global and national regulatory requirements, the therapeutic development process, and available technologies to identify and evaluate the relevance of potential patient risks have required both extensive revision to every chapter and the addition of a number of new chapters. They address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (including carcinogenicity, developmental toxicity, immunogenicity and immunotoxicity) to provide both understanding and guidance for approaching new problems.