Nonclinical Development of Biologics, Vaccines and Specialty Biologics:
Plitnick, Lisa |
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ISBN 13: 9780443133442 Previous ISBN (13): 9780123948106 ISBN 10: 0443133441 Category: Toxicology Edition: 2 Publisher: Elsevier Publication Date: 10/2024 Format: Cloth Status: Not Yet Published Imprint: Academic Press Audience: Professional and scholarly Pages: 450 Weight: 0.99 Retail Price: 175.00 (Tentative Price May Change) Quantity On Hand: 0 Quantity On Order: 0 |
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Synopsis: 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. This multi-edited book with chapters authored by leading qualified experts in the field offers a comprehensive reference on critical insights that will be of interest to researchers involved in early through late-stage biologics.
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