Clinical Trial Simulations Applications and Trends
This edition presents a review of the principles and progress surrounding clinical trial simulations (CTS), along with case studies illustrating CTS in various therapeutic and application areas. In addition, the book expands on the utility of CTS fo
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Volume I: Clinical Trial Simulations: Applications and Trends Holly H.C. Kimko and Carl C. Peck
Holly H. C. Kimko
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Carl C. Peck
Editors
Clinical Trial Simulations Applications and Trends
Editors Holly H.C. Kimko Johnson & Johnson Pharmaceutical Research & Development, LLC Advanced Modeling & Simulation Raritan, NJ USA [email protected]
Carl C. Peck Center for Drug Development Science Department of Bioengineering and Therapeutic Sciences Schools of Pharmacy and Medicine University of California San Francisco, CA USA [email protected]
ISSN 2210-7371 e-ISSN 2210-738X ISBN 978-1-4419-7414-3 e-ISBN 978-1-4419-7415-0 DOI 10.1007/978-1-4419-7415-0 Springer New York Dordrecht Heidelberg London # American Association of Pharmaceutical Scientists 2011 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 ScienceþBusiness Media (www.springer.com)
Preface
During the seven years following the inaugural publication of Simulation for Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Perspective, acceptance and application of clinical trials modeling and simulation (M&S) in drug development and regulation have greatly expanded. Biopharmaceutical companies have employed M&S in all phases of drug development to achieve greater efficiency and dosage optimization. The food and Drug Administration’s (FDA) visionary 2004 Critical Path Initiative highlighted clinical trial simulations (CTS) in “model based drug development” to facilitate efficient development. In the meantime, FDA and the European Medicines Agency have encouraged use of CTS via regulatory guidances, and have employed M&S for labeling and approval decisions. On the backdrop of these developments, the title of this edition has been chosen to reflect how CTS is being employed in drug development and regulation, and trends for expanded applications in the future. This edition includes updates, new uses, and issues concerning CTS, along with case studies on how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the use of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. Editors’ opinions on advances and impactful tren
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