Includes bibliographic references and index.

Drug discovery, metabolism, and pharmacokinetics -- Toxicological studies and ind application, and first in-human clinical trial -- Clinical pathology, hispathology, and biomakers -- Biostatis, regulatory toxicology, and role of srudy directors -- Specialty route of administration -- Nonclinical development of monoclonal antibodies, stem cells, oncogenic and non-oncogenic drugs, olignucleotides and vaccines -- Safety evaluation of ocular drugs, botanical products, and medical devices -- Predictive toxicology, toxicmetabolimics, toxicogenomics, and imaging

Is a valuable refernces designed to provide a complete understanding of all aspects of nonclinical toxicolgy in the development of small molecules and biologics, including vaccines and botanical products.