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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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Liczba stron: 1489
Edited by
HONGHUI ZHOUFRANK-PETER THEIL
Copyright © 2016 by John Wiley & Sons, Inc. All rights reserved
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