ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins - Honghui Zhou - ebook

ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins ebook

Honghui Zhou

539,99 zł


With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. * Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs * Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective * Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines * Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan * Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain

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Applications in Drug Discovery and Development


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Published by John Wiley & Sons, Inc., Hoboken, New JerseyPublished simultaneously in Canada

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Library of Congress Cataloging-in-Publication Data:

ADME and translational pharmacokinetics/pharmacodynamics of therapeutic proteins : applications in drug discovery and development / edited by Honghui Zhou, Frank-Peter Theil.  p. ; cm. Includes bibliographical references and index.

 ISBN 978-1-118-89864-2 (hardback)I. Zhou, Honghui, editor. II. Theil, Frank-Peter, editor.[DNLM: 1. Antibodies, Monoclonal–therapeutic use. 2. Protein Engineering. 3. Proteins–pharmacokinetics. 4. Drug Discovery. QU 55.95] RM301.5 615.7–dc23      2015024770


Omoniyi J. Adedokun

, Janssen Research and Development, LLC, Spring House, PA, USA

Bo An

, Department of Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY, USA

Andreas Baumann

, Bayer Pharma Aktiengesellschaft, Berlin, Germany

C. Andrew Boswell

, Genentech Research and Early Development, South San Francisco, CA, USA

David Canter

, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA

Yanguang Cao

, State University of New York at Buffalo, Buffalo, NY, USA; The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

Alan L. Epstein

, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA

Thierry Flandre

, Novartis Pharma AG, Basel, Switzerland

Gert Fricker

, Ruprecht-Karls University Heidelberg, Heidelberg, Germany

Ludivine Fronton

, Roche Pharmaceutical Research and Early Development, Basel, Switzerland

Saskia Fuhrmann

, Universität Potsdam Institute of Biochemistry and Biology, Potsdam, Germany; Freie Universität Berlin, Berlin, Germany

María J. Garrido

, University of Navarra, Pamplona, Spain

Megan Gibbs

, Clinical Pharmacology, Modeling and Simulation, Amgen Inc., Thousand Oaks, CA, USA

José David Gómez-Mantilla

, University of Navarra, Pamplona, Spain

Chao Han

, Janssen Research & Development, LLC, Spring House, PA, USA

Tae H. Han