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Full Description
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.
Contents
1. Introduction The discipline of Clinical Pharmacology Markus Muller; Professor of Clinical Pharmacology, Vienna, Austria Example: EACPT - position paper Current issues in drug development Markus Muller; Professor of Clinical Pharmacology, Vienna, Austria Example: Pfizer Current issues in drug regulation Marcus Mullner / 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: Nurnberg, Helsinki, Belmont GCP, Scientific misconduct Brigitte Blochl-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.Garhofer; 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 Muller; Professor of Clinical Pharmacology, Vienna, Austria Example: Alzheimer Vaccine Advanced therapies Bernd Jilma; Professor of Clinical Pharmacology, Vienna, Austria Example: Gene Therapy Individualization Markus Muller; Professor of Clinical Pharmacology, Vienna, Austria Example: breast cancer Generic drugs, Enantiomers, mee-too's, biosimilars Brigitte Blochl-Daum; Professor of Clinical Pharmacology, Vienna, Austria Example: PPIs Special situations, market fragmentation 1: Pediatric and elderly populations, Orphan drugs Brigitte Blochl-Daum/ Christoph Male; Professor of Clinical Pharmacology, Vienna, Austria Professor of Pediatrics, Vienna, Austria Example: EMEA pediatric plan Special situations, market
