Current issues in drug development
Historically, pharmaceutical therapy has been extraordinarily successful in combating and alleviating various diseases. Common life threatening diseases, most notably infections, have extremely satisfying therapeutic success rates and many serious disease
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Markus Muller Editor
Clinical Pharmacology: Current Topics and Case Studies
Univ.-Prof. Dr. Markus Miiller Professor and Head of Department, Department of Clinical Pharmacology Medical Un iversity Vienna, Vienna General Hospital (AKH) Vienna , Austria
This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically those of translation, reprinting, re-use of illustrations, broadcasting, reproduction by photocopying machines or similar mean s, and storage in data banks. Product Liability: The publisher can give no guarantee for all the information contained in this book. This does also refer to information about drug dosage and application thereof. In every individual case the respective user must check its accuracy by consulting other pharmaceutical literature. © 2010 Springer-VerlaglWien Printed in Austria Springer- Verlag Wien New York is part of Springer Science + Business Media springer.at Typesetting: Thomson Press (Indi a) Ltd., Chennai, India Printing: Holzhausen Druck GmbH, 1140 Wien, Austria Printed on acid-free and chlorine-free bleached paper SPIN: 12695102 With 45 (partly coloured) Figures Library of Congress Control Number: 2010930251
ISBN 978-3-7091-0143-8 SpringerWienNewYork
CONTENTS
List of Contributors
XIX
SECTION 1: Introduction Chapter 1 The discipline of Clinical Pharmacology (Markus Muller) Chapter 2 Current issues in drug development (Markus Muller) 1 2 3 4 5
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Historical success 7 The dawn of a molecular era)the "druggable genome" and market fragmentation Inno vation and stagnation 10 The development of EBM methodology 12 Issues in preclinical and clinical drug development 12 5.1 Target and drug candidate identification 12 5.2 Preclinical drug development 12 5.3 Clinical drug development 13 6 The role of academic medicine 15 7 Confidence crisis and public opinion 15 8 Conclusion 16 Case Study: Pfizer 16
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Chapter 3 Current issues in drug regulation (Marcus Muller,
Hans-Georg Eichler)
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1 The drug regulators ' decision-making 19 2 Authorizing a medicinal product in the EU 20 2.1 The Centralized Authorization 22 2.2 The Mutual Recognition Procedure (MRP) and the Decentralized Procedure (DCP) 23 2.3 The national procedure 24
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Contents
3 Regulatory life-cycle management of medicinal products 24 3.1 From efficacy to post-marketing relative effectiveness assessment 3.2 Pharmacovigilance and signal detection 26 3.3 Risk management plans (RMPs) 27 3.4 When should a medicinal product be authorized? 28 Case Study: Efalizumab (Raptiva) 29
Chapter 4 Current issues in drug reimbursement (Anna Bucsics) 1 Introduction 33 2 Reimbursement principles in general
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3 Relative effectiveness - background 35 4 Relative effectiveness case study - data submitted for reimbursement in Austria
(Anna Bucsics, Valerie Nell-Duxneuner)
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Introduction 36 Methods 36 Results 37 Interpretation 38 MEDEV - local payers vs. global payers 38 The Pharmaceutical Forum 39 Results 41 7.1 Good principles 41 7.2 Data for relative ef
