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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
Hardcover
ISBN13: 9780123948106
Publisher: Academic Press
Published: Jul 19 2013
Pages: 432
Weight: 2.35
Height: 1.10 Width: 7.60 Depth: 9.40
Language: English
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines 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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