Incorporating Clinical Biomarkers into Clinical Trials
Clinical trials are required for testing the safety and efficacy of new drugs produced by the pharmaceutical industry. These trials also serve to provide information on clinical and survival benefits, prediction of treatment responses, identification of p
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Russell Weiner Marian Kelley Editors
Translating Molecular Biomarkers into Clinical Assays Techniques and Applications
AAPS Advances in the Pharmaceutical Sciences Series Volume 37
Editors-in-chief Daan J.A. Crommelin, Utrecht University, Utrecht, Utrecht, The Netherlands Robert A. Lipper, Back Cove Pharma, LLC, Waldoboro, ME, USA
The AAPS Advances in the Pharmaceutical Sciences Series, published in partnership with the American Association of Pharmaceutical Scientists, is designed to deliver volumes authored by opinion leaders and authorities from around the globe, addressing innovations in drug research and development, and best practice for scientists and industry professionals in the pharma and biotech industries.
More information about this series at http://www.springer.com/series/8825
Russell Weiner Marian Kelley •
Editors
Translating Molecular Biomarkers into Clinical Assays Techniques and Applications
123
Editors Russell Weiner Translational Biomarkers and Personalized Medicine Edison, NJ USA
Marian Kelley MKelley Consulting LLC West Chester, PA USA
ISSN 2210-7371 ISSN 2210-738X (electronic) AAPS Advances in the Pharmaceutical Sciences Series ISBN 978-3-319-40792-0 ISBN 978-3-319-40793-7 (eBook) DOI 10.1007/978-3-319-40793-7 Library of Congress Control Number: 2016943065 © American Association of Pharmaceutical Scientists 2016 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer International Publishing AG Switzerland
Preface
The science of drug development is an evolutionary one, something we can see clearly in the world of biomarkers. Not so long ago the concept of using biomarkers in drug development was relegated to a few “research-only” kits. Bioanalysis in support of drug development focused solely on the pharmacokinetics (PK) of new drug entities. Unfortunately, PK-only approaches can no longer support today’s drug development targets.
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