Drug Safety Evaluation Methods and Protocols
This second edition provides up-to-date chapters and new chapters focusing on the most recent advances in the field of drug safety evaluation. Divided into seven parts, chapters detail specific aspects related to the experimental design of preclinical stu
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Jean-Charles Gautier Editor
Drug Safety Evaluation Methods and Protocols Second Edition
Methods
in
Molecular Biology
Series Editor John M. Walker School of Life and Medical Sciences University of Hertfordshire Hatfield, Hertfordshire, AL10 9AB, UK
For further volumes: http://www.springer.com/series/7651
Drug Safety Evaluation Methods and Protocols Second Edition
Edited by
Jean-Charles Gautier Preclinical Safety, Sanofi, R&D, Vitry-sur-Seine, France
Editor Jean-Charles Gautier Preclinical Safety Sanofi, R&D Vitry-sur-Seine, France
ISSN 1064-3745 ISSN 1940-6029 (electronic) Methods in Molecular Biology ISBN 978-1-4939-7170-1 ISBN 978-1-4939-7172-5 (eBook) DOI 10.1007/978-1-4939-7172-5 Library of Congress Control Number: 2017944283 © Springer Science+Business Media LLC 2017 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. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Printed on acid-free paper This Humana Press imprint is published by Springer Nature The registered company is Springer Science+Business Media LLC The registered company address is: 233 Spring Street, New York, NY 10013, U.S.A.
Preface Nonclinical 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 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. The volume Drug Safety Evaluation Methods and Prot
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