Schlagwörter
drug research, pharmacokinetics, drug development, clinical trial, Alzheimer, clinical research, gene therapy, research, pharmacology, vaccine, siRNA, ethics, pharmacodynamics, kinetics, drug
Inhaltsverzeichnis
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