This book covers the entire clinical development continuum from selection of lead candidate to first in human studies to ultimate product approval. Devoted to the principles and practices of preclinical safety evaluation, the book is divided into eight parts including (Part I) background, which provides definitions and methods of production of biopharmaceuticals; (Part II) discussion of the principles of ICHS6 regulations and the global implementation of the principles;   (Part III) current practices and comparisons to small molecule development; (Part IV) the importance and criteria for selection of relevant species;   (Part V) a consideration of the various  toxicity endpoints as they relate to biopharmaceuticals; (Part VI) specific considerations based upon each product class;   (Part VII) practical considerations in design, implementation and analysis of biopharmaceuticals and finally (Part VIII) the ultimate transition to clinical trials.  The parts of the book are self contained but may be inter related or cross referenced for more general or specific details.