Pharmaceutical Statistics MBSW 39, Muncie, Indiana, USA, May 16-18,
This book presents the proceedings of the 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW), held in Muncie, Indiana on May 16–18, 2016. It consists of selected peer- reviewed and revised papers on topics ranging from statistical applicatio
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Ray Liu Yi Tsong Editors
Pharmaceutical Statistics MBSW 39, Muncie, Indiana, USA, May 16–18, 2016
Springer Proceedings in Mathematics & Statistics Volume 218
Springer Proceedings in Mathematics & Statistics This book series features volumes composed of selected contributions from workshops and conferences in all areas of current research in mathematics and statistics, including operation research and optimization. In addition to an overall evaluation of the interest, scientific quality, and timeliness of each proposal at the hands of the publisher, individual contributions are all refereed to the high quality standards of leading journals in the field. Thus, this series provides the research community with well-edited, authoritative reports on developments in the most exciting areas of mathematical and statistical research today.
More information about this series at http://www.springer.com/series/10533
Ray Liu Yi Tsong •
Editors
Pharmaceutical Statistics MBSW 39, Muncie, Indiana, USA, May 16–18, 2016
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Editors Ray Liu Statistical Innovation and Consultation Group Takeda Pharmaceuticals Cambridge, MA, USA
Yi Tsong Division of Biometrics VI, CDER U.S. Food and Drug Administration Silver Spring, MD, USA
ISSN 2194-1009 ISSN 2194-1017 (electronic) Springer Proceedings in Mathematics & Statistics ISBN 978-3-319-67385-1 ISBN 978-3-319-67386-8 (eBook) https://doi.org/10.1007/978-3-319-67386-8 Library of Congress Control Number: 2019933200 Mathematics Subject Classification (2010): 62-06, 62-07, 62-09, 62H12, 62H15, 62H20, 65C20, 65C60, 92-08, 97M60 © Springer Nature Switzerland AG 2019 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, expressed 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. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Contents
Part I
Specification and Sampling Acceptance
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