Drug Development (DD)
Kursnummer: DD |
Kursname: Drug Development |
Gesamtstunden: 150 h |
ECTS Punkte: 5 ECTS |
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Kurstyp: Pflicht Kursangebot : WS, SS Course Duration : 1 Semester |
Zugangsvoraussetzungen: None |
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Kurskoordinator(en) / Dozenten / Lektoren: Siehe aktuelle Liste der Tutoren im Learning Management System |
Bezüge zu anderen Modulen: Siehe Modulbeschreibung |
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Beschreibung des Kurses: The course describes the discovery and selection of compounds for human diseases and the paradigm shift from a random search to a rational approach. The requirements of preclinical development, pharmacokinetics, and pharmacodynamics, drug interactions, and bioequivalence as well as the phases of clinical development from Phase I – IV will be discussed. Course Objectives and Outcome: On successful completion of this module, students will be able to:
Teaching Methods: This course is taught in blended format. It consists of 120 h directed, remote learning (via recorded presentations, self-readings, and exercises), followed by 4 days of full-time, face-to-face training in form of lectures, supplemented by class discussions. Class discussions refer to the concepts being introduced and case studies. Course Content: 1 Overview and History 2 Current Trends in Drug Development 3 Target Selection and Preclinical Development 4 Rational Approach versus Serendipity 5 Guidelines for Preclinical Research 6 Scaling from Animal to Human 7 Pharmacokinetics: Physiology, Physicochemistry and Mathematical Description of Absorption, Distribution, Metabolism, and Excretion of Drugs 8 Phase I Studies: First in Human Studies, Safety and Tolerability, Drug Interaction and Bioequivalence: Aims and Study Design 9 Phase II-IV Studies: From Proof of Concept to Post Marketing Surveillance |
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Literatur: • Hill, R. G., & Rang, H. P. (Eds.). (2013). Drug discovery & development: Technology in transition (2nd ed.). London: Churchill Livingston Elsevier. |
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Prüfungszugangsvoraussetzung: • Course evaluation |
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Prüfungsleistung: • Research essay, 15-20 pages (DIN A4) |
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Student Workload (in hours): 150 Lectures: 30 |