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.
€245.03
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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, si RNAs 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, marketОб авторе
Markus Müller, MD, born August 23, 1967 is a board certified specialist in Internal Medicine and Clinical Pharmacology. He has been trained in Austria, Sweden and the US and currently serves as tenured, full Professor and Head of the Department of Clinical Pharmacology of the Vienna Medical University at the Vienna General Hospital (AKH). He is responsible for ~ 80 staff members. The Department is specialized on clinical research in a wide variety of therapeutic areas and on the development of novel drugs in close collaboration with the pharmaceutical industry. Prof Müller serves on numerous national and international boards (e.g. council member of the European Association for Clinical Pharmacology and Therapeutics; Chairman of the Pharmacological Expert Committee, Association of Austrian Social Insurance Institutions; European Expert, European Medicines Agency (EMEA), London, UK; adjunct faculty member University of Florida, USA). He has also served as chairman of an FDA workshop and is a delegate of the Standing Committee of the European Medical Research Council. Prof. Müller is (Co) Inventor of 2 patents and has received several awards, e.g. the 2004 Tanabe Award of the American College of Clinical Pharmacology (ACCP) in acknowledgement of innovations in clinical pharmacology trials. He is deputy editor of the International Journal of Clinical Pharmacology and Therapeutics and reviewer for numerous scientific journals. He has published > 170 peer reviewed articles, e.g. in the New England Journal of Medicine, Nature Medicine or the British Medical Journal.
язык английский ● Формат PDF ● страницы 430 ● ISBN 9783709101445 ● Размер файла 48.3 MB ● редактор Markus Müller ● издатель Springer Wien ● город Vienna ● Страна AT ● опубликованный 2011 ● Загружаемые 24 месяцы ● валюта EUR ● Код товара 2205082 ● Защита от копирования Социальный DRM
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