Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics:
Plitnick, Lisa |
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ISBN 13: 9780123948106 ISBN 10: 012394810X Category: Toxicology Edition: 1 Publisher: Elsevier Copyright: 2013 Format: Cloth Status: Print on Demand Imprint: Academic Press Affiliation: Merck & Co., Inc., West Point, PA Audience: Professional and scholarly Dimensions: 9.25 x 1.1 x 7.5 in Pages: 432 Weight: 2.36 Retail Price: 174.95 Quantity On Hand: 0 |
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Synopsis: Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. 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. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. |
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