DRUG BENEFITS AND RISKS
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Drug Benefits and Risks International Textbook of Clinical Pharmacology
Revised 2nd edition
Edited by
Chris J. van Boxtel University of Amsterdam, Amsterdam, The Netherlands
Budiono Santoso World Health Organization, Manila, The Philippines
I. Ralph Edwards WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Amsterdam • Washington, DC
© 2008 The authors. All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without prior written permission from the publisher. ISBN 978-1-58603-880-9 Library of Congress Control Number: 2008930693 Revised 2nd edition, 2008 Publishers IOS Press Nieuwe Hemweg 6B 1013 BG Amsterdam The Netherlands fax: +31 20 687 0019 e-mail:
[email protected]
Distributor in the UK and Ireland Gazelle Books Falcon House Queen Square Lancaster LA1 1RN United Kingdom fax: +44 1524 63232
Uppsala Monitoring Centre Box 1051 75140 Uppsala Sweden
Distributor in the USA and Canada IOS Press, Inc. 4502 Rachael Manor Drive Fairfax, VA 22032 USA fax: +1 703 323 3668 e-mail:
[email protected]
The first edition (2001) was published by John Wiley & Sons, LTD, under ISBN 978-0-471-89927-3.
LEGAL NOTICE The publishers are not responsible for the use which might be made of the following information. PRINTED IN THE NETHERLANDS
Contents Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ix
Foreword to the Second Edition . . . . . . . . . . .
xv
Foreword to the First Edition . . . . . . . . . . . . . xvii
7 Medicines in Developing Countries . . . . . Budiono Santoso, Kathleen Holloway, Hans V. Hogerzeil and Valerio Reggi
79
8 Drug Information . . . . . . . . . . . . . . . . . . . . Ylva Böttiger and Anders Rane
99
Preface to the Second Edition . . . . . . . . . . . . . xix Preface to the First Edition . . . . . . . . . . . . . . . xxi
9 Drug Development . . . . . . . . . . . . . . . . . . . 107 Michel Briejer and Peter van Brummelen
Section I
General Principles . . . . . . . . . . . . .
1
Part B General Clinical Pharmacology . . . 121
Part A Medicinals in Society . . . . . . . . . . . .
1
10 Clinical Pharmacokinetics . . . . . . . . . . . . 123 Anthony J. Smith and Sri Suryawati
3 3
11 Clinical Pharmacodynamics . . . . . . . . . . . 165 Gunnar Alvan, Gilles Paintaud and Monique Wakelkamp
1 The Role of Therapeutic Agents in Modern Medicine . . . . . . . . . . . . . . . . . . . . A Drug Benefits . . . . . . . . . . . . . . . . . . . . . Ronald D. Mann B Drug Risks . . . . . . . . . . . . . . . . . . . . . . . Jerry Avorn 2 Therapeutics as a Science . . . . . . . . . . . . . Marcus M. Reidenberg 3 Pharmacoepidemiology and Drug Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . Supornchai