Drug Safety Evaluation Methods and Protocols
Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ul
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Molecular Biology™
Series Editor John M. Walker School of Life Sciences University of Hertfordshire Hatfield, Hertfordshire, AL10 9AB, UK
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Drug Safety Evaluation Methods and Protocols
Edited by
Jean-Charles Gautier Disposition, Safety and Animal Research, sanofi-aventis, Vitry-sur-Seine, France
Editor Jean-Charles Gautier Disposition, Safety and Animal Research sanofi-aventis Vitry-sur-Seine France [email protected]
ISSN 1064-3745 e-ISSN 1940-6029 ISBN 978-1-60327-186-8 e-ISBN 978-1-60761-849-2 DOI 10.1007/978-1-60761-849-2 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2010937423 © Springer Science+Business Media, LLC 2011 All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Humana Press, c/o 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. While the advice and information in this book are believed to be true and accurate at the date of going to press, 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, express or implied, with respect to the material contained herein. Printed on acid-free paper Humana Press is part of Springer Science+Business Media (www.springer.com)
Preface Non-clinical drug safety evaluation is the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals. The main objectives of drug safety evaluation studies are to differentiate between new drug entities that are unacceptably toxic and those that are not, characterize the potential adverse effects of new drugs, determine animal dosage levels that do not cause toxicity, and to estimate safe dosages to be used in clinical studies. Several types of studies are conducted in drug safety evaluation: acute to chronic general toxicity studies, reproductive toxicity studies, genotoxicity studies, carcinogenicity studies, safety pharmacology studies, and investigative toxicity studies. General toxicity studies are usually performed in a rodent and in a nonrodent species to determine target organs of toxicity and evaluate doses of a new drug candidate that can be safely administered to man. In this book, specific aspects related to the experimental design of toxicity studies conducted to
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