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Development of Antibody-Based Therapeutics: Translational Considerations

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ISBN 10: 144195953X / ISBN 13: 9781441959539
Published by Springer
New Condition New Hardcover
From BuySomeBooks (Las Vegas, NV, U.S.A.) Quantity Available: 20
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Hardcover. 426 pages. Dimensions: 9.2in. x 6.2in. x 1.2in.Translational strategies for development of antibody-based therapeutics should allow understanding of the relationship between the unit dose and unit effect with respect to both beneficial and deleterious effects from early stages of development. The flow of information from later to earlier stages of development should provide opportunities to facilitate selection of more effective novel and next-generation drug candidates. Selection and evaluation of relevant biomarkers in early preclinical development in relevant animal models should allow for identifying potential risks to humans and establishing safe First-In-Human (FIH) dosing strategies. Hence, integration of knowledge with respect to target antigen properties such as antigen distribution, expression profile, kinetic properties, target pharmacology, antigen isoforms and pharmacological redundancy in health and disease, as well as antibody design criteria, such as antibody isotype, affinity, PKPD and safety is a critical necessity for the design of effective translational strategies. Additionally, these factors will further offer critical differentiating characteristics for next-generation antibodies, and novel technologies prove instrumental in generation of biosuperior antibody candidates for market entry. This book will examine many important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics. This item ships from multiple locations. Your book may arrive from Roseburg,OR, La Vergne,TN. Bookseller Inventory # 9781441959539

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Translational strategies for development of antibody-based therapeutics should allow understanding of the relationship between the ?unit dose? and ?unit effect? with respect to both beneficial and deleterious effects from early stages of development. The flow of information from later to earlier stages of development should provide opportunities to facilitate selection of more effective novel and next-generation drug candidates. Selection and evaluation of relevant biomarkers in early preclinical development in "relevant" animal models should allow for identifying potential risks to humans and establishing safe First-In-Human (FIH) dosing strategies. Hence, integration of knowledge with respect to target antigen properties such as antigen distribution, expression profile, kinetic properties, target pharmacology, antigen isoforms and pharmacological redundancy in health and disease, as well as antibody design criteria, such as antibody isotype, affinity, PK/PD and safety is a critical necessity for the design of effective translational strategies. Additionally, these factors will further offer critical differentiating characteristics for next-generation antibodies, and novel technologies prove instrumental in generation of biosuperior antibody candidates for market entry. This book will examine many important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics.

From the Back Cover: 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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Bibliographic Details

Title: Development of Antibody-Based Therapeutics: ...

Publisher: Springer

Binding: Hardcover

Book Condition: New

Book Type: Hardcover

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