Nonclinical Development of Biologics, Vaccines and Specialty Biologics, Second Edition, is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, vaccines, cell and gene therapies, and oncology therapeutics. Updated and revised, the new edition compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory guidelines. This book discusses the different types of biologics, as well as early characterization strategies, principles of study design, nonclinical pharmacokinetics and pharmacodynamics, nonclinical assays, and regulatory guidelines. A coedited book with chapters authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late-stage biologics.

• Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical
• Discusses the most pertinent international regulatory guidelines
• Covers early derisking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines