A Review of Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials

The 40 chapters of the book, encompassing approximately 1,000 pages, address the chronology of biopharmaceutical development from species selection during preclinical safety assessment to various types of toxicology studies needed to support progression of clinical trials in humans with a vision to new product registration. Survey of Preclinical Toxicology Programs for Approved Biopharmaceuticals (by Dr. Anita Marie O'Connor) Chapter 39 will prove useful to toxicologists, as well as regulatory affairs professionals, due to its catalog of the types of toxicology studies (with animal species) done as part of the US applications for registration of multiple biopharmaceutical products, with some examples as recent as 2006.