Clinical Pharmacology: Current Topics And Case Studies

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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.

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E-Book Information

• Year: 2,010

• Edition: 1st Edition.

• Pages: 456

• Pages In File: 456

• Language: English

• Topic: 173

• Identifier: 3709101433,9783709101438

• Paginated: 1

• Org File Size: 47,811,625

• Extension: pdf

• Tags: Медицинские дисциплины Фармакология Клиническая фармакология и фармакотерапия

• Toc: Cover......Page 1Clinical Pharmacology: Current Topics and Case Studies......Page 3ISBN 9783709101438......Page 4Table of Contents......Page 6LIST OF CONTRIBUTORS......Page 20SECTION 1 Introduction......Page 27CHAPTER 1 The discipline of Clinical Pharmacology......Page 29References......Page 311 Historical success......Page 332 The dawn of a molecular era, the "druggable genome" and market fragmentation......Page 343 Innovation and stagnation......Page 365.2 Preclinical drug development......Page 385.3 Clinical drug development......Page 397 Confidence crisis and public opinion......Page 418 Conclusion......Page 42References......Page 43Further reading......Page 441 The drug regulators' decision-making......Page 452 Authorizing a medicinal product in the EU......Page 462.1 The Centralized Authorization......Page 482.2 The Mutual Recognition Procedure (MRP) and the Decentralized Procedure (DCP) [8]......Page 493 Regulatory life-cycle management of medicinal products......Page 503.1 From efficacy to post-marketing relative effectiveness assessment......Page 513.2 Pharmacovigilance and signal detection......Page 523.3 Risk management plans (RMPs)......Page 533.4 When should a medicinal product be authorized?......Page 54References......Page 561 Introduction......Page 592 Reimbursement principles in general......Page 603 Relative effectiveness - background......Page 614.2 Methods......Page 624.3 Results......Page 635 MEDEV - local payers vs. global payers......Page 646 The Pharmaceutical Forum......Page 657.1 Good principle