Pharmacokinetics in Drug Development Advances and Applications, Volu
The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for assessment of selected special development p
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Peter L. Bonate • Danny R. Howard Editors
Pharmacokinetics in Drug Development Volume 3: Advances and Applications
Editors Peter L. Bonate, Ph.D. Clinical Pharmacology, Modeling, and Simulation GlaxoSmithKline Research Triangle Park, NC, USA [email protected]
Danny R. Howard, Ph.D. Translational Sciences Novartis East Hanover, NJ, USA [email protected]
ISBN 978-1-4419-7936-0 e-ISBN 978-1-4419-7937-7 DOI 10.1007/978-1-4419-7937-7 Springer New York Heidelberg Dordrecht London Library of Congress Control Number: 2011922160 # American Association of Pharmaceutical Scientists 2011 All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
Preface
The primary objective of this book series is to provide readers with practical guidance on the application of pharmacokinetics as a drug development science. Our goal has been, and continues to be, to provide the link between the theoretical and the applied. We ask every author to write their chapter with this question in the back of their mind: “If you were training someone new to industry, what about this topic should they know?” In the first two volumes, topics were chosen specifically for their relative “stability” and they represented the core what we do as a profession. Though the approaches and technologies may have advanced, the practical considerations for topics like bioavailability study designs, analysis procedures for absorption data or dose-proportionality, or the role of pharmacokinetics in early development have remained relatively consistent over time. Some of the topics, however, have changed and some become more prominent over time. With this volume, we begin to address the more “adaptable” issues facing pharmacokineticists and pharmacologists supporting new compound development. The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for the assessment of selected special development populations. For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis of tumor growth modeling, and for disease progression modeling. Practical considerations for metabolite safety te
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