Safety Evaluation of Pharmaceuticals and Medical Devices Internation
Safety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through th
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Shayne C. Gad
Safety Evaluation of Pharmaceuticals and Medical Devices International Regulatory Guidelines
Shayne C. Gad Gad Consulting Services Cary, NC USA [email protected]
ISBN 978-1-4419-7448-8 e-ISBN 978-1-4419-7449-5 DOI 10.1007/978-1-4419-7449-5 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2010937640 © 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 (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. Photo credit: Peter Atkins - fotolia.com Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
To my baby brother, Scott Michael Gad (1950-2010)
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Preface
The inspiration for this text was the 1988 volume by Alder and Zbinden*, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and the practice of medicine and regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology and combination product fields) in a concise, abbreviated manner for all the major world market countries. As when teaching on the subject of drug safety evaluation, the approach I have taken here is to first address the broadest scope “general case” for the regulatory nonclinical safety evaluation by ICH and ISO adhering countries, then to branch out to cover the differences in requirements associated with specific therapeutic areas (such as oncology), major routes of administration (with oral being the general case, other routes starting with parenteral, dermal, and inhalation are addressed). Large molecules biotechnology products are then considered, followed by special courses of product marketing approval, and finally the remaining national differences. As will be seen, even for ICH countries there is (in mid-2009) continuing modification of the basic M3 guidance for small molecule drugs (R2 being released in step 2 in August of 2008) and S6 (for protein therapeutics) series guidances, and it is not expected that the situation captured and guidance offered in th
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