Pharmaceutical Experimental Design

Pharmaceutical Experimental Design Gareth A. Lewis Synthelabo Recherche Chilly Mazarin, France Didier Mathieu University of the Mediterranean Marseille, France Roger Phan-Tan-Luu University of Law, Economics, and Science of Aix-Marseille Marseille, France MARCEL MARCEL DEKKER, INC. D E K K E R TM Copyright n 1999 by Marcel Dekker, Inc. All Rights Reserved. NEW YORK • BASEL ISBN: 0-8247-9860-0 This book is printed on acid-free paper. Headquarters Marcel Dekker, Inc. 270 Madison Avenue, New York, NY 10016 tel: 212-696-9000; fax: 212-685-4540 Eastern Hemisphere Distribution Marcel Dekker AG Hutgasse 4, Postfach 812, CH-4001 Basel, Switzerland tel: 44-61-261-8482; fax: 44-61-261-8896 World Wide Web http://www.dekker.com The publisher offers discounts on this book when ordered in bulk quantities. For more information, write to Special Sales/Professional Marketing at the headquarters address above. Copyright © 1999 by Marcel Dekker, Inc. All Rights Reserved. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage and retrieval system, without permission in writing from the publisher. Current printing (last digit): 10 9 8 7 6 5 4 3 PRINTED IN THE UNITED STATES OF AMERICA TM Copyright n 1999 by Marcel Dekker, Inc. All Rights Reserved. DRUGS AND THE PHARMACEUTICAL SCIENCES Executive Editor James Swarbrick AAI, Inc. Wilmington, North Carolina Advisory Board Larry L. Augsburger University of Maryland Baltimore, Maryland Douwe D. Breimer Gorlaeus Laboratories Leiden, The Netherlands Trevor M. Jones The Association of the British Pharmaceutical Industry London, United Kingdom Hans E. Junginger Leiden/Amsterdam Center for Drug Research Leiden, The Netherlands Vincent H. L. Lee University of Southern California Los Angeles, California David E. Nichols Purdue University West Lafayette, Indiana Stephen G. Schulman University of Florida Gainesville, Florida Jerome P. Skelly Copley Pharmaceutical, Inc. Canton, Massachusetts Felix Theeuwes Alza Corporation Palo Alto, California Geoffrey T. Tucker University of Sheffield Royal Hallamshire Hospital Sheffield, United Kingdom Peter G. Welling Institut de Recherche Jouveinal Fresnes, France TM Copyright n 1999 by Marcel Dekker, Inc. All Rights Reserved. DRUGS AND THE PHARMACEUTICAL SCIENCES A Series of Textbooks and Monographs 1. Pharmacokinetics, Milo Gibaldi and Donald Perrier 2. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Sidney H. W/l/ig, Murray M. Tuckerman, and William S, Hitch ings IV 3. Microencapsulation, edited by J. R. Nixon 4. Drug Metabolism: Chemical and Biochemical Aspects, Bernard Testa and Peter Jenner 5. New Drugs: Discovery and Development, edited by Alan A. Rubin 6. Sustained and Controlled Release Drug Delivery Systems, edited by Joseph R. Robinson 7. Modern Pharmaceutics, edited by Gilbert S. Banker and Christopher T. Rhodes 8. Prescription Drugs in Short Supply: Case Histories, Michael A. Schwartz 9. Activated Charcoal: Antidotal and Other Medical Uses, David O. Cooney 10. Concepts in Drug Metabolism (in two parts), edited by Peter Jenner and Bernard Testa 11. Pharmaceutical Analysis: Modern Methods (in two parts), edited by James W. Munson 12. Techniques of Solubilization of Drugs, edited by Samuel H. Yalkowsky 13. Orphan Drugs, edited by Fred E. Karch 14. Novel Drug Delivery Systems: Fundamentals, Developmental Concepts, Biomedical Assessments, Yie W. Chien 15. Pharmacokinetics: Second Edition, Revised and Expanded, Milo Gibaldi and Donald Perrier