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.

1. IntroductionThe discipline of Clinical PharmacologyMarkus Müller; Professor of Clinical Pharmacology, Vienna, AustriaExample: EACPT - position paperCurrent issues in drug developmentMarkus Müller; Professor of Clinical Pharmacology, Vienna, AustriaExample: PfizerCurrent issues in drug regulationMarcus Müllner / Hans Georg Eichler; Professor and Head, Austrian Medicines Agency AGES, Vienna, Austria / Professor and Senior Medical Officer, EMEA, London, UKExample: EMEACurrent issues in drug reimbursementAnna Bucsics; Medical Director, Austrian Board of Social Security InstitutionsExample: comparative effectiveness2. Clinical TrialsEthics of clinical researchErnst Singer; Professor and Head, Ethics Committee, Medical University Vienna, AustriaExample: Nürnberg, Helsinki, BelmontGCP, Scientific misconductBrigitte Blöchl-Daum; Professor of Clinical Pharmacology, Vienna, AustriaExample: Tuskegee, VioxxPhases of drug development, first in man studiesBernd Jilma; Professor of Clinical Pharmacology, Vienna, AustriaExample: TegeneroClinical trials - interventional studiesMichael Wolzt; Professor of Internal Medicine, Vienna, AustriaExample: CASTClinical trials - observational studiesCh. Male / H. Herkner; Professor of Pediatrics, Vienna, Austria/ Professor of Internal Medicine, Vienna, AustriaExample: CDC 'Outbreak'Pharmacokinetics / PharmacodynamicsHartmut Derendorf; Professor of Pharmaceutics, University of Florida, USAExample: Antibiotic drug developmentMicrodosingGraham Lappin; Medical Director, Exceleron, UKExample: CREAM trialEpidemiology, statisticsL.Schmetterer / G.Garhöfer; Professor of Physics, Vienna, Austria/ Professor of Clinical Pharmacology, Vienna, AustriaExample: Star signs (multiple hypothesis testing)PlaceboeffectsJohannes Pleiner; Professor of Clinical Pharmacology, Vienna, AustriaExample: Arthroscopy3. Tools in Clinical PharmacologyImagingOliver Langer; Professor of Radiopharmaceutics, Vienna, AustriaExample: AprepitantGenomics, Pharmacogenomics, druggable genomeWolfgang Schmidt; Consultant of Genetics, Vienna, AustriaExample: AbacavirBiomarkersVolker Wacheck; Consultant of Internal Medicine, Vienna, AustriaExample: CholesterolMolecular tools in drug research - translational medicineVolker Wacheck; Consultant of Internal Medicine, Vienna, AustriaExample: knockout animals - ACE2 (Apeiron)4. Topics in Clinical PharmacologyPharmaceutical drug safetyMartin Brunner; Professor of Clinical Pharmacology, Vienna, AustriaExample: LipobayDrug InteractionsMarkus Zeitlinger; Professor of Clinical Pharmacology, Vienna, AustriaExample: Saint-John's-wortBiological pharmaceuticals: antibodies, proteins, siRNAsMarkus Müller; Professor of Clinical Pharmacology, Vienna, AustriaExample: Alzheimer VaccineAdvanced therapiesBernd Jilma; Professor of Clinical Pharmacology, Vienna, AustriaExample: Gene TherapyIndividualizationMarkus Müller; Professor of Clinical Pharmacology, Vienna, AustriaExample: breast cancerGeneric drugs, Enantiomers, mee-toös, biosimilarsBrigitte Blöchl-Daum; Professor of Clinical Pharmacology, Vienna, AustriaExample: PPIsSpecial situations, market fragmentation 1: Pediatric and elderly populations, Orphan drugsBrigitte Blöchl-Daum/ Christoph Male; Professor of Clinical Pharmacology, Vienna, Austria Professor of Pediatrics, Vienna, AustriaExample: EMEA pediatric planSpecial situations, market