Regulated Bioanalysis: Fundamentals and Practice
This book is intended to cover the fundamental and practical aspects of regulated bioanalysis. The editors are seeking leading scientists in the field to participate in the development of this book, which we envision as a “one of a kind” contribution to o
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Mario L. Rocci Jr. Stephen Lowes Editors
Regulated Bioanalysis: Fundamentals and Practice
AAPS Advances in the Pharmaceutical Sciences Series Volume 26
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
Mario L. Rocci Jr. Stephen Lowes •
Editors
Regulated Bioanalysis: Fundamentals and Practice
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Editors Mario L. Rocci Jr. Laboratory Services ICON, Plc Whitesboro, NY USA
Stephen Lowes Bioanalytical and ADME Labs Q Squared Solutions Ithaca, NY USA
ISSN 2210-7371 ISSN 2210-738X (electronic) AAPS Advances in the Pharmaceutical Sciences Series ISBN 978-3-319-54800-5 ISBN 978-3-319-54802-9 (eBook) DOI 10.1007/978-3-319-54802-9 Library of Congress Control Number: 2017933942 © American Association of Pharmaceutical Scientists 2017 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. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer International Publishing AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
To my beloved wife and son, Donna and Mark Rocci for all the love, encouragement and support they’ve provided throughout my professional career. —Mario L. Rocci Jr. To Kathy, Thea and Elise Lowes—my loving family and all I hold dear. —Stephen Lowes
Preface
Bioanalysis, simply described as the quantit
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