Clinical Pharmacology: Current Topics And Case Studies
E-Book Overview
Today we witness an eventful time in which the powerful new forces of genomics, information technology and economics are rapidly changing the science and art of medicine. This will require more specialization than ever before. However, there is also an increasing demand for an integrated approach, which is provided by the discipline of Clinical Pharmacology (CP). CP pursues a scientific goal by studying drug action in patients and volunteers, a clinical goal by administering appropriate drug therapy and a regulatory goal by assessing the risk/benefit ratio of drug candidates in drug development and reimbursement. This introduction to current topics of CP covers traditional topics of clinical drug research and trial methodology but also provides insight in current topics like genomics, imaging technology and issues in drug reimbursement. A number of concrete case studies in clinical drug research and development help to give a better understanding of the general principles of CP.
E-Book Information
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Year: 2,010
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Edition: 1st Edition.
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Pages: 456
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Pages In File: 456
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Language: English
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Topic: 173
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Identifier: 3709101433,9783709101438
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Paginated: 1
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Org File Size: 47,811,625
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Extension: pdf
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Tags:
Медицинские дисциплины
Фармакология
Клиническая фармакология и фармакотерапия
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Toc: Cover......Page 1 Clinical Pharmacology: Current Topics and Case Studies......Page 3 ISBN 9783709101438......Page 4 Table of Contents......Page 6 LIST OF CONTRIBUTORS......Page 20 SECTION 1 Introduction......Page 27 CHAPTER 1 The discipline of Clinical Pharmacology......Page 29 References......Page 31 1 Historical success......Page 33 2 The dawn of a molecular era, the "druggable genome" and market fragmentation......Page 34 3 Innovation and stagnation......Page 36 5.2 Preclinical drug development......Page 38 5.3 Clinical drug development......Page 39 7 Confidence crisis and public opinion......Page 41 8 Conclusion......Page 42 References......Page 43 Further reading......Page 44 1 The drug regulators' decision-making......Page 45 2 Authorizing a medicinal product in the EU......Page 46 2.1 The Centralized Authorization......Page 48 2.2 The Mutual Recognition Procedure (MRP) and the Decentralized Procedure (DCP) [8]......Page 49 3 Regulatory life-cycle management of medicinal products......Page 50 3.1 From efficacy to post-marketing relative effectiveness assessment......Page 51 3.2 Pharmacovigilance and signal detection......Page 52 3.3 Risk management plans (RMPs)......Page 53 3.4 When should a medicinal product be authorized?......Page 54 References......Page 56 1 Introduction......Page 59 2 Reimbursement principles in general......Page 60 3 Relative effectiveness - background......Page 61 4.2 Methods......Page 62 4.3 Results......Page 63 5 MEDEV - local payers vs. global payers......Page 64 6 The Pharmaceutical Forum......Page 65 7.1 Good principle