Pharmaceutical Stability Testing to Support Global Markets
The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this
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Biotechnology: Pharmaceutical Aspects Volume I: Pharmaceutical Profiling in Drug Discovery for Lead Selection R.T. Borchardt, E.H. Kerns, C.A. Lipinski, D.R. Thakker, B. Wang Volume II: Lypophilization of Biopharmaceuticals H.R. Constantino, M.J. Pikal Volume III: Methods for Structural Analysis of Protein Pharmaceuticals W. Jiskoot, D.J.A. Crommelin Volume IV: Optimizing the “Drug-Like” Properties of Leads in Drug Discovery R.T. Borchardt, E.H. Kerns, M.J. Hageman, D.R. Thakker, J.L. Stevens Volume V: Prodrugs: Challenges and Rewards, Parts 1 and 2 V.J. Stella, R.T. Borchardt, M.J. Hageman, R. Oliyai, H. Maag, J.W. Tilley Volume VI: Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics P. Augustijns, M.E. Brewster Volume VII: Drug Absorption Studies: In Situ, In Vitro and In Silico Models C. Ehrhardt, K.J. Kim Volume VIII: Immunogenicity of Biopharmaceuticals M. van de Weert, E. H. Møller Volume IX: Advances in Bioactivation Research A. Elfarra Volume X: Nanotechnology in Drug Delivery M. M. de Villiers, P. Aramwit, G. S. Kwon Volume XI: Current Trends in Monoclonal Antibody Development and Manufacturing S.J. Shire, W. Gombotz, K. Bechtold-Peters, J. Andya Volume XII: Pharmaceutical Stability Testing to Support Global Markets K. Huynh-Ba
Pharmaceutical Stability Testing to Support Global Markets
Edited by
Kim Huynh-Ba Pharmalytik Newark, DE USA
Editor Kim Huynh-Ba Pharmalytik Newark, DE USA [email protected]
ISBN 978-1-4419-0888-9 e-ISBN 978-1-4419-0889-6 DOI 10.1007/978-1-4419-0889-6 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2009939690 © 2010 American Association of Pharmaceutical Scientists All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
Preface
The International Conference of Harmonization (ICH) has worked on harmonizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways
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