Safety Pharmacology of Drugs with Osteoarthritis-Related Activity
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H. Gerhard Vogel (Ed.) Franz Jakob Hock Jochen Maas Dieter Mayer (Co-Editors)
Drug Discovery and Evaluation Safety and Pharmacokinetic Assays With 131 Figures and 125 Tables
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Hans Gerhard Vogel Bohl Str. 28 73430 Aalen Germany [email protected]
ISBN-10: 3-540-25638-5 ISBN-13: 978-3-540-25638-0 This publication is available also as: Electronic publication under ISBN 3-540-29804-5 and Print and electronic bundle under ISBN 3-540-33442-4
Library of Congress Control Number: 2006928067 This work is subject to copyright. All rights are reserved, 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 other ways, and storage in data banks. Duplication of this publication or parts thereof is only permitted under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law. Springer is part of Springer Science+Business Media springer.com c Springer-Verlag Berlin Heidelberg New York 2006 Printed in Germany The use of registered names, trademarks, 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. Product liability: The publishers cannot guarantee the accuracy of any information about the application of operative techniques and medications contained in this book. In every individual case the user must check such information by consulting the relevant literature. Editor: Thomas Mager, Heidelberg Development Editor: Andrew Spencer, Heidelberg Production Editor: Frank Krabbes, Heidelberg Cover Design: Frido Steinen-Broo, Spain Printed on acid-free paper
SPIN: 10981627 2109 - 5 4 3 2 1 0
Preface
Drug discovery and evaluation has been a sequential process for a long period of time. It started with the selection of the most active compound from a series of newly synthesized compounds with the help of special pharmacological assays. Safety aspects were considered by testing the selected compound in high doses in tests directed to indications other than the intended indication of the new compound. These tests were followed by pharmacokinetic studies, which were mainly aimed at confirmation of a suitable half-life time and of oral activity. Safety relied on acute and subacute toxicity studies, which gave information more on organ structure than on organ function. Toxicological and pharmacokinetic studies were adapted to the progress of studies in clinical pharmacology and clinical trails. This strategy has been changed during the last 15 years for several reasons: Some negative effects on organ function, e.g., ventricular tachy-arrhythmia were detected too late. On the other hand, negative findings in chronic toxicity studies in animals turned out to be irrelevant for hum
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