Sterile Product Development Formulation, Process, Quality and Regula
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:• Formulation
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Parag Kolhe Mrinal Shah Nitin Rathore Editors
Sterile Product Development Formulation, Process, Quality and Regulatory Considerations
AAPS Advances in the Pharmaceutical Sciences Series The AAPS Advances in the Pharmaceutical Sciences Series, published in partnership with the American Association of Pharmaceutical Scientists, is designed to deliver well written volumes authored by opinion leaders and authoritarians 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. For more details and to see a list of titles in the Series please visit http://www.springer.com/series/8825
Series Editors Daan J.A. Crommelin Robert A. Lipper
Parag Kolhe • Mrinal Shah • Nitin Rathore Editors
Sterile Product Development Formulation, Process, Quality and Regulatory Considerations
Editors Parag Kolhe Pharmaceutical R&D-BioTx Pharmaceutical Sciences Pfizer, Chesterfield, MO, USA
Mrinal Shah LifeCell Corporation Bridgewater, NJ, USA
Nitin Rathore Drug Product Technology Amgen, Thousand Oaks CA, USA
ISSN 2210-7371 ISSN 2210-738X (electronic) ISBN 978-1-4614-7977-2 ISBN 978-1-4614-7978-9 (eBook) DOI 10.1007/978-1-4614-7978-9 Springer New York Heidelberg Dordrecht London Library of Congress Control Number: 2013948456 © American Association of Pharmaceutical Scientists 2013 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. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher’s location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. 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. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty,
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