Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics PDF
By:Lisa Plitnick,Danuta Herzyk
Published on 2013-06-27 by Academic Press
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. Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical Contains the most pertinent international regulatory guidance documents for nonclinical evaluation Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or |biosimilars| A multi-authored book with chapters written by qualified experts in their respective fields
This Book was ranked at 16 by Google Books for keyword Pharmacodynamics.
Book ID of Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics's Books is U0wEcrLkozYC, Book which was written byLisa Plitnick,Danuta Herzykhave ETAG "R8jk4XTSbWY"
Book which was published by Academic Press since 2013-06-27 have ISBNs, ISBN 13 Code is 9780123948236 and ISBN 10 Code is 0123948231
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Book which have "432 Pages" is Printed at BOOK under CategoryMedical
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