This need has been formally identified by the pharmaceutical industry as the Quality by Design (QbD) initiative and has been in the center of attention over the last few years. Printed on acid-free paper Humana Press is a brand of Springer Springer Science+Business Media LLC New York is part of Springer Science+Business Media (Preface The need for a more structured approach to process and product development has been recently identified in the pharmaceutical industry in order to consistently guarantee quality and value to processes and products. 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, 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.
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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 use of general descriptive names, registered names, trademarks, service marks, etc. 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. ISSN 1557-2153 ISSN 1940-6053 (electronic) Methods in Pharmacology and Toxicology ISBN 978-1-4939-2995-5 ISBN 978-1-4939-2996-2 (eBook) DOI 10.1007/978-1-4939-2996-2 Library of Congress Control Number: 2015949385 Springer New York Heidelberg Dordrecht London # Springer Science+Business Media New York 2016 This work is subject to copyright. Rohit Ramachandran Rutgers University Piscataway, NJ, USA Ierapetritou Rutgers University Piscataway, NJ, USA Ierapetritou and Rohit Ramachandran Rutgers University, Piscataway, NJ, USAĮditors Marianthi G.
Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture Edited by James Kang University of Louisville School of Medicine Prospect, Kentucky, USA Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture
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