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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Plitnick, Lisa M. PhD

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Book Information
Edition:	1st
Publisher:	Academic Press, Incorporated
ISBN:	0-12-394823-1 (0123948231)
ISBN-13:	978-0-12-394823-6 (9780123948236)
Binding:	E E Book + ProQuest Ebook Central
Copyright:	2013
Publish Date:	07/13
Weight:	0.00 Lbs.
Subject Class:	PHM (Pharmacy and Pharmaceutical Industry)
Remarks:	A New Edition of this title is due 08/24
Return Policy:	Non-Returnable.
Table Of Contents:	View

ProQuest Ebook Centralï¿½:	Please sign in to preview this title

Class Specifications
Discipline:	Pharmacology
Subject Definition:	Biopharmaceutics; Models, Chemical; Pharmacokinetics
NLM Class:	QV 38
LC Class:	RM301.4
Abstract:	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. 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.

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