Clinical Pharmacology: Current Topics and Case Studies - Current Topics and Case Studies

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.

List of contents

1. Introduction
The discipline of Clinical Pharmacology
Markus Müller; Professor of Clinical Pharmacology, Vienna, Austria
Example: EACPT - position paper
Current issues in drug development
Markus Müller; Professor of Clinical Pharmacology, Vienna, Austria
Example: Pfizer
Current issues in drug regulation
Marcus Müllner / Hans Georg Eichler; Professor and Head, Austrian Medicines Agency AGES, Vienna, Austria / Professor and Senior Medical Officer, EMEA, London, UK
Example: EMEA
Current issues in drug reimbursement
Anna Bucsics; Medical Director, Austrian Board of Social Security Institutions
Example: comparative effectiveness
2. Clinical Trials
Ethics of clinical research
Ernst Singer; Professor and Head, Ethics Committee, Medical University Vienna, Austria
Example: Nürnberg, Helsinki, Belmont
GCP, Scientific misconduct
Brigitte Blöchl-Daum; Professor of Clinical Pharmacology, Vienna, Austria
Example: Tuskegee, Vioxx
Phases of drug development, first in man studies
Bernd Jilma; Professor of Clinical Pharmacology, Vienna, Austria
Example: Tegenero
Clinical trials - interventional studies
Michael Wolzt; Professor of Internal Medicine, Vienna, Austria
Example: CAST
Clinical trials - observational studies
Ch. Male / H. Herkner; Professor of Pediatrics, Vienna, Austria/ Professor of Internal Medicine, Vienna, Austria
Example: CDC 'Outbreak'
Pharmacokinetics / Pharmacodynamics
Hartmut Derendorf; Professor of Pharmaceutics, University of Florida, USA
Example: Antibiotic drug development
Microdosing
Graham Lappin; Medical Director, Exceleron, UK
Example: CREAM trial
Epidemiology, statistics
L.Schmetterer / G.Garhöfer; Professor of Physics, Vienna, Austria/ Professor of Clinical Pharmacology, Vienna, Austria
Example: Star signs (multiple hypothesis testing)
Placeboeffects
Johannes Pleiner; Professor of Clinical Pharmacology, Vienna, Austria
Example: Arthroscopy

3. Tools in Clinical Pharmacology
Imaging
Oliver Langer; Professor of Radiopharmaceutics, Vienna, Austria
Example: Aprepitant
Genomics, Pharmacogenomics, druggable genome
Wolfgang Schmidt; Consultant of Genetics, Vienna, Austria
Example: Abacavir
Biomarkers
Volker Wacheck; Consultant of Internal Medicine, Vienna, Austria
Example: Cholesterol
Molecular tools in drug research - translational medicine
Volker Wacheck; Consultant of Internal Medicine, Vienna, Austria
Example: knockout animals - ACE2 (Apeiron)

4. Topics in Clinical Pharmacology

Pharmaceutical drug safety
Martin Brunner; Professor of Clinical Pharmacology, Vienna, Austria
Example: Lipobay

Drug Interactions
Markus Zeitlinger; Professor of Clinical Pharmacology, Vienna, Austria
Example: Saint-John's-wort

Biological pharmaceuticals: antibodies, proteins, siRNAs
Markus Müller; Professor of Clinical Pharmacology, Vienna, Austria
Example: Alzheimer Vaccine

Advanced therapies
Bernd Jilma; Professor of Clinical Pharmacology, Vienna, Austria
Example: Gene Therapy

Individualization
Markus Müller; Professor of Clinical Pharmacology, Vienna, Austria
Example: breast cancer

Generic drugs, Enantiomers, mee-too s, biosimilars
Brigitte Blöchl-Daum; Professor of Clinical Pharmacology, Vienna, Austria
Example: PPIs

Special situations, market fragmentation 1: Pediatric and elderly populations, Orphan drugs
Brigitte Blöchl-Daum/ Christoph Male; Professor of Clinical Pharmacology, Vienna, Austria Professor of Pediatrics, Vienna, Austria
Example: EMEA pediatric plan

Special situations, market

About the author

Prof. Markus Müller, MD is Head of the Department of Clinical Pharmacology at the Medical University of Vienna in Austria. He is specialized in Internal Medicine and Clinical Pharmacology and is an international expert in clinical research. He has published over 80 articles on the use and methodology of microdialysis in clinical drug development.

Product details

• Assisted by: Marku Müller (Editor), Markus Müller (Editor)
• Publisher: Springer, Wien
• Languages: English
• Product format: Hardback
• Released: 12.08.2010
• EAN: 9783709101438
• ISBN: 978-3-7091-0143-8
• No. of pages: 430
• Weight: 878 g
• Illustrations: w. 40 figs.
• Subject: Natural sciences, medicine, IT, technology > Medicine > Pharmacy