Development of Antibody-Based Therapeutics: Translational Considerations

Tabrizi, Mohammad A.

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Book Information
Edition:	1st
Publisher:	Springer
ISBN:	1-4419-5953-X (144195953X)
ISBN-13:	978-1-4419-5953-9 (9781441959539)
New Edition:	981-1304-95-5
Binding:	Hardcover
Copyright:	2012
Publish Date:	06/12
Weight:	0.00 Lbs.
Pages:	550
Subject Class:	PHM (Pharmacy and Pharmaceutical Industry)
Remarks:	A New Edition of this Title is Available
Return Policy:	Returns accepted up to 12 months provided no other recalls or return restrictions apply.
Table Of Contents:	View
ProQuest Ebook Central:	Available in ProQuest Ebook Central™ View

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Abstract:

Development of Antibody-Based Therapeutics: Translational Considerations examines important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics. Translational strategies for development of antibody-based therapeutics require an understanding of the relationship between the .unit dose' and .unit effect' with respect to both beneficial and deleterious biological effects from early stages of development. The flow of information across various stages of development should provide opportunities to facilitate selection of more effective novel and next-generation drug candidates. Successful strategies for the development of monoclonal antibodies require integration of knowledge with regards to target antigen properties in health and disease, as well as antibody design criteria including affinity, isotype selection, pharmacokinetics/pharmacodynamics (PK/PD) properties, antibody cross-reactivity across species, and safety. Selection and evaluation of appropriate biomarkers in early preclinical development in "relevant" animal models should allow identification of potential risks and liabilities of an antibody drug candidate to humans and establishment of safe First-In-Human (FIH) dosing strategies. This volume provides a comprehensive review of the topics critical for establishing successful translational strategies for the development of antibody-based therapeutics.

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