| Description |
1 online resource (xxiv, 430 pages) |
| Contents |
Cover13; -- Table of Contents -- List Of Contributors -- Section 1 Introduction -- Chapter 1 The Discipline of Clinical Pharmacology -- Acknowledgement -- References -- Chapter 2 Current Issues in Drug Development -- 1 Historical Success -- 2 The Dawn of a Molecular Era, the "Druggable Genome" and Market Fragmentation -- 3 Innovation and Stagnation -- 4 The Development of Ebm Methodology -- 5 Issues in Preclinical and Clinical Drug Development -- 6 The Role of Academic Medicine -- 7 Confidence Crisis and Public Opinion -- 8 Conclusion -- Acknowledgement -- References -- Further Reading -- Chapter 3 Current Issues in Drug Regulation -- 1 The Drug Regulators' Decision-Making -- 2 Authorizing a Medicinal Product in the Eu -- 3 Regulatory Life-Cycle Management of Medicinal Products -- Disclaimer -- References -- Chapter 4 Current Issues in Drug Reimbursement -- 1 Introduction -- 2 Reimbursement Principles in General -- 3 Relative Effectiveness -- Background -- 4 Relative Effectiveness Case Study -- Data Submitted for Reimbursement in Austria -- 5 Medev -- Local Payers Vs. Global Payers -- 6 The Pharmaceutical Forum -- 7 Results -- 8 Looking Forward -- 9 In the Future -- Building a European System of Assessing Relative Effectiveness -- Acknowledgements -- Disclaimer -- References -- Section 2 Clinical Trials -- Chapter 5 Ethics in Clinical Research -- 1 Development of World-Wide Standards in Clinical Research Ethics -- 2 Research Ethics Committees Today -- Function and Composition -- 3 Research Ethics Committees -- Issues of Debate -- 4 Compensation for Committee Members -- References -- Chapter 6 Good Clinical Practice (Gcp) and Scientific Misconduct -- Good Clinical Practice -- Research Misconduct -- Acknowledgement -- References -- Chapter 7 Phase-I Studies and First-in-Human Trials -- 1 Introduction -- 2 Definition Phase I -- 3 General Considerations for Phase-I Studies, Trial Design and Study Protocol -- 4 Preclinical Development -- 5 Choice of Subjects, Study Population -- 6 Dose Finding -- 7 Route and Rate of Administration -- 8 Clinical Environment -- References -- Further Reading -- Chapter 8 Clinical Trials -- Interventional Studies -- 1 Introduction -- 2 Types of Clinical Trials -- 3 Randomization -- 4 Blinding -- 5 Different Study Designs -- 6 Study Endpoint -- 7 Interim Analyses -- References -- Chapter 9 Observational Studies -- 1 Introduction -- 2 Methodological Principles -- 3 Overview of Study Design Types -- References -- Further Reading -- Chapter 10 Pharmacokinetics I: Pk-Pd Approaches -- Antibiotic Drug Development -- 1 Pk-Pd Approach -- 2 Microdialysis for Measuring Free Drug Concentrations -- 3 Md Calibration Methods -- 4 Md and Tissue Penetration of Antibiotics -- 5 Microdialysis and Pk-Pd -- 6 Kill Curves -- 7 Experimental Settings of in Vitro Models -- 8 Conclusion -- References -- Chapter 11 Pharmacokinetics II: 14C-Labelled Microdosing in Assessing Drug Pharmacokinetics At Phase-O |
| Summary |
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 |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| In |
Springer eBooks |
| Subject |
Pharmacology.
|
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Clinical pharmacology.
|
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Pharmacology, Clinical -- trends
|
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Pharmacology, Clinical
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Pharmacology
|
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pharmacology.
|
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Biomédecine.
|
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Sciences de la vie.
|
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Clinical pharmacology
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Pharmacology
|
| Genre/Form |
Case studies.
|
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Études de cas.
|
| Form |
Electronic book
|
| Author |
Müller, Markus
|
| ISBN |
9783709101445 |
|
3709101441 |
|
1283074591 |
|
9781283074599 |
|
