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.
Content Level » Research
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Table 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)
Placebo effects
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 fragmentation 2: sex – differences
Ghazaleh Gouya; Consultant of Internal Medicine, Vienna, Austria
Example: CHD
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