Nonclinical Development of Biologics, Vaccines and Specialty Biologics

Book excerpt: Nonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics, Second Edition is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. 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. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. A multi-edited book with chapters authored by leading qualified 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