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    Clinical Pharmacology: Current Topics and Case Studies

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    عدد المساهمات : 1204
    تاريخ التسجيل : 28/10/2009
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    Clinical Pharmacology: Current Topics and Case Studies

    مُساهمة من طرف d-forum في 25/03/11, 04:38 pm



    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













    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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