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

ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins ebook

Honghui Zhou

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Opis

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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ADME AND TRANSLATIONAL PHARMACOKINETICS/PHARMACODYNAMICS OF THERAPEUTIC PROTEINS

Applications in Drug Discovery and Development

 

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

LIST OF CONTRIBUTORS

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