New Drug Development An Introduction to Clinical Trials: Second Edit
New Drug Development, 2nd Edition, is a reader-friendly introduction to clinical trials that is written specifically for entry-level professionals in the pharmaceutical, biopharmaceutical, and contract research organization (CRO) industries. It is also ex
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J. Rick Turner
New Drug Development An Introduction to Clinical Trials: Second Edition
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J. Rick Turner Cardiac Safety Services Quintiles 4820 Emperor Boulevard Durham, NC 27703, USA [email protected]
ISBN 978-1-4419-6417-5 e-ISBN 978-1-4419-6418-2 DOI 10.1007/978-1-4419-6418-2 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2010930851 © Springer Science+Business Media, LLC 2010 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)
Sample of Published Review Comments for the First Edition of New Drug Development
The author has the uncanny ability to reveal the essence of a complex topic without bogging down in superficialities. (Journal of Clinical Research Best Practices) The book gives a refreshing run through of the drug discovery and development process and it is probably the book you need to have to learn about this fascinating field. (Journal of Applied Statistics) This volume would provide an excellent introduction for anyone entering the pharmaceutical industry. It would also make superb background reading in medical statistics for MSc students. (International Statistical Review)
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For Karen, Charlie, Mishadow, Misty, and Mac
Foreword
While passion in any worthwhile pursuit is to be commended, passion about a process that affects the lives of many millions of people throughout the world is particularly so. Pharmaceutical products improve health and quality of life on a scale that is unrivaled by any other medical intervention. Before these drugs are prescribed by physicians, they go through an extremely rigorous process that investigates their safety and their efficacy: This is the process of new drug development. This investigation is conducted under the governance of regulatory agencies throughout the world. In the United States, the Food and Drug Administration (FDA) shoulders this responsibility. Nonclinical investigation in animals and clinical investigation in humans must be conducted in a specified manner, and all results must be submitted to the FDA in appropriately formatted documentation to achieve marketing approval. Although Dr. Turner’s exposition is simple and straightforward, successful new drug development is a complex process that requires the integration of careful study de
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