E-Book Overview
These multidisciplinary presentations provide information essential to devising effective drug protocols in cardiovascular drug development, facilitating the approval process. Guides researchers and developers through the government drug approval process, facilitating development, minimizing costs, and harmonizing international standards employed in the creation of vital new cardiovascular therapies! Cardiovascular Drug Development ·explores the delicate balance of efficacy and safety that cardiovascular therapy must achieve to gain regulatory approval ·discusses the search for surrogates and the need in some areas for natural history endpoints ·reviews optimum strategies for protocol design in the development of drugs to treat hypertension, cardiac arrhythmias, heart failure, coronary artery disease, and hypercholesterolemia and other lipid disorders ·compares and contrasts the varying standards of evidence for drug approval in the United States, Europe, and Asia ·and more! Cardiovascular Drug Development will prove to be a valuable asset for cardiologists, pharmacologists and pharmacists, regulatory affairs specialists, and directors of research and development for pharmaceutical companies.
E-Book Content
Cardiovascular Drug Development Protocol Design and Methodology
edited by
Jeffrey S. Borer The Joan and Sanford I. Weill Medical College of Cornell University and The New York Presbyterian Hospital-Cornell Medical Center New York, New York
J.ohn C. Somberg Rush University and Rush Presbyterian-St. Luke’s Medical Center Chicago, Illinois
M A R C E L
MARCELDEKKER, INC. D E K K E R
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NEWYORK BASEL HONGKONC
Cardiovascular Drug Development
ISBN: 0-8247-1927-1 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 2 1 PRINTED IN THE UNITED STATES OF AMERICA
FUNDAMENTAL AND CLINICAL CARDIOLOGY
Editor-in-Chief
Samuel Z. Goldhaber, M.D. Harvard Medical School and Brigham and Women's Hospital Boston, Massachusetts
Associate Editor, Europe
Henri Bounameaux, M.D. University Hospital of Geneva Geneva, Switzerland
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