Non-Biological Complex Drugs The Science and the Regulatory Landscap
The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the com
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Series Editors Daan J. A. Crommelin Utrecht University, Utrecht, The Netherlands Robert A. Lipper Back Cove Pharma, LLC, Waldoboro, Maine, USA
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 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. For more details and to see a list of titles in the Series please visit http://www. springer.com/series/8825
Daan J.A. Crommelin • Jon S. B. de Vlieger Editors
Non-Biological Complex Drugs The Science and the Regulatory Landscape
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Editors Daan J.A. Crommelin Utrecht University Utrecht The Netherlands
Jon S. B. de Vlieger Top Institute Pharma NBCD Working Group Leiden The Netherlands
ISSN 2210-7371 ISSN 2210-738X (Electronic) AAPS Advances in the Pharmaceutical Sciences Series ISBN 978-3-319-16240-9 ISBN 978-3-319-16241-6 (eBook) DOI 10.1007/978-3-319-16241-6 Library of Congress Control Number: 2015940779 Springer Cham Heidelberg New York Dordrecht London © Springer International Publishing Switzerland 2015 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 Springer is part of Springer Science+Business Media (www.springer.com)
Contents
Introduction: Defining the Position of Non-Biological Complex Drugs����� 1 Daan J. A. Crommelin, Jon S. B. de Vlieger and Stefan Mühlebach Part I Non Biological Complex Drugs Polymeric Micelles������������������������������������������������������������������������������������������� 11 Ethlinn V.B. van Gaal and Daan J.A. Crommelin Liposomes: The Science and the Regulatory Landscape����������������������������� 77 Daan J.A. Crommelin, Josbert M. Metselaar and Gert Storm Glatiramoids�������������������������������������������������������������
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