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G. Alexander Fleming - Optimizing Therapeutic Development in Diabetes

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Diabetes Mellitus is estimated to affect over 124 million individuals worldwide. The rising prevalence of type 1 diabetes and the projected global increase in type 2 diabetes attests to the urgent need for the development of safer and more effective treatment strategies. This book provides an overview of the latest developments in diabetes research, and critically assesses both current therapies and potential new treatment compounds. Methodological aspects of clinical trials in diabetes and related regulatory issues are examined in detail. Key features Written by an experienced team of authors with a proven track record in publishing for this market Up-to-date and comprehensive coverage of recent clinical trials and research studies Features a useful evaluation of future trends in diabetes research and treatment

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title Optimizing Therapeutic Development in Diabetes author - photo 1

title:Optimizing Therapeutic Development in Diabetes
author:Fleming, G. Alexander.
publisher:Greenwich Medical Media Limited
isbn10 | asin:1841100382
print isbn13:9781841100388
ebook isbn13:9780511043451
language:English
subjectDiabetes Mellitus--therapy, Diabetes.
publication date:1999
lcc:RC658.5.O68 1999eb
ddc:616.462
subject:Diabetes Mellitus--therapy, Diabetes.
Page i
Optimizing Therapeutic Development in Diabetes
Page ii
To the millions of children and adults who battle with diabetes every
moment of the day, and to the many thousands of health
professionals, investigators, and pharmaceutical developers who
have joined the patients to defeat this disease.
Page iii
Optimizing Therapeutic Development in Diabetes
G. Alexander Fleming1
Stanford S. Jhee2
Robert F. Coniff3
Henry J. Riordan4
Michael F. Murphy3
Neil M. Kurtz3
and
Neal R. Cutler2
Picture 2Picture 3
1 Worldwide Clinical Trials, Washington, D.C., USA
Picture 4Picture 5
2 California Clinical Trials, Beverly Hills, CA, USA
Picture 6Picture 7
3 Worldwide Clinical Trials, Atlanta, GA, USA
Picture 8Picture 9
4 Worldwide Clinical Trials, Philadelphia, PA, USA
Page iv
1999
Greenwich Medical Media Ltd.
137 Euston Road
London
NW1 2AA
ISBN 184110 038 2
First Published 1999
While the advice and information in this book is believed to be true and accurate, neither the authors nor the publisher can accept any legal responsibility or liability for any loss or damage arising from actions or decisions based in this book. The ultimate responsibility for the treatment of patients and the interpretation lies with the medical practitioner. The opinions expressed are those of the authors and the inclusion in this book relating to a particular product, method or technique does not amount to an endorsement of its value or quality, or of the claims made of it by its manufacture. Every effort has been made to check drug dosages; however, it is still possible that errors have occurred. Furthermore, dosage schedules are constantly being revised and new side effects recognised. For these reasons, the medical practitioner is strongly urged to consult the drug companies' printed instructions before administering any of the drugs mentioned in this book.
Apart from any fair dealing for the purposes of research or private study, or criticism or review, as permitted under the UK Copyright Designs and Patents Act, 1988, this publication may not be reproduced, stored, or transmitted, in any form or by any means, without the prior permission in writing of the publishers, or in the case of reprographic reproduction only in accordance with the terms of the licenses issued by the Copyright Licensing Agency in the UK, or in accordance with the terms of the licenses issued by the appropriate Reproduction Rights Organization outside of the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publishers at the London address printed above.
The rights of Drs. G.A. Fleming, S.S. Jhee, R.F. Coniff, H.J. Riordan, M.F. Murphy, N.M. Kurtz, and N.R. Cutler to be identified as the authors of this work have been asserted by them in accordance with the Copyright, Designs, and Patents Act 1988.
The publisher makes no representation, express or implied, with regard to the accuracy of the information contained in this book and cannot accept any legal responsibility or liability for any errors or omissions that may be made.
A catalogue record for this book is available from the British Library
Distributed worldwide by
Oxford University Press
Project Manager
Gavin Smith
Production and Design by
Janis H. Schaap
Printed in Great Britain
Page v
Foreword
An explosion in interest in diabetes mellitus and its treatment has occurred over the last two decades. As the economic and social costs of diabetes continue to rise due to an increasing prevalence of diabetes both in the U.S. and throughout the world, the imperative to identify successful approaches to therapy increases as well. This book provides a rationale for drug discovery and development efforts directed at diabetes and its complications.
Diabetes mellitus accounts for approximately 15% of health care dollars spent in the U.S. and approximately 25% of Medicare dollars. Diabetes mellitus is the leading single cause of adult-onset blindness and end-stage renal disease. Diabetes also increases the risk of coronary heart disease and stroke, and these complications represent the major causes of the increased morbidity and mortality associated with diabetes. Nearly 60% of dollars spent for the care of diabetes in 1997 were directed at costs arising from hospitalization for the care of diabetic complications. Thus, with the aging of the U.S. population, the increased risk of developing diabetes in the older population, the increasing corpulence of the U.S. population and its impact on the development of diabetes, and a worldwide epidemic of diabetes in countries moving from poverty to prosperity, there is a clear mandate to improve the care of patients with diabetes. New therapies should be efficacious, safe, and affordable. With "evidence-based" medicine forming the underpinnings of both drug approval by regulatory agencies and payment for drug costs by insurance companies and other third-party payers, new approaches must be undertaken to identify and test new agents to treat diabetes and its complications.
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