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| Semester | Herbstsemester 2023 |
| Angebotsmuster | Jedes Herbstsemester |
| Dozierende | Mark Deurinck (mark.deurinck@unibas.ch, BeurteilerIn) |
| Inhalt | Why do we perform animal experiments? How do we perform them? Who is regulating theme? Are we working on alternative tests? We will be discussing the principles, regulations and ethics of non-clinical studies, study design and endpoints, interpretation and application of results, in drug development. Lecturers will be joining us from industry and academia, on a much appreciated voluntary basis. Program overview (chronological order may vary): - Animal Experimentation for Regulatory Purposes: Introduction to the module - Species-specific Effects in Toxicity: Understanding and extrapolation to humans - Regulatory toxicology: Health hazard assessment of drugs in the frame of regulations - Toxicology: Study types, dose, species, study duration; basic study protocol; technologies - Safety Pharmacology: Cardiovascular endpoints and models used in drug development - Haematology, Clinical Chemistry, Urinalysis: Basic principles - Mode of action and biological targets: pharmacology and toxicology; human extrapolation - In silico tools for development of biologics - Regulatory Toxicology for pharmaceutical intermediates - Reproductive Toxicology: Studies and interpretation of results for human risk assessment - Ethics in Animal Experimentation and legal requirements - Carcinogenicity studies and in vivo genotoxicity - Risk assessment for patient safety in manufacturing, incl. case study |
| Lernziele | Understand scientific and regulatory background of preclinical animal studies conducted during development and registration of drugs and chemicals and the interpretation of data for human health risk assessment. |
| Literatur | Provided during the lecture period |
| Bemerkungen | Film and sound recordings during the course are strictly forbidden (recorders may be confiscated) |
| Weblink | Department of Pharmaceutical Sciences |
| Teilnahmebedingungen | Completed Bachelor degree |
| Anmeldung zur Lehrveranstaltung | |
| Unterrichtssprache | Englisch |
| Einsatz digitaler Medien | kein spezifischer Einsatz |
| Intervall | Wochentag | Zeit | Raum |
|---|---|---|---|
| wöchentlich | Mittwoch | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Datum | Zeit | Raum |
|---|---|---|
| Mittwoch 20.09.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 27.09.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 04.10.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 11.10.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 18.10.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 25.10.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 01.11.2023 | 15.15-17.00 Uhr | - Siehe Bemerkung, Examination weeks |
| Mittwoch 08.11.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 15.11.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 22.11.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 29.11.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 06.12.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 13.12.2023 | 15.15-17.00 Uhr | Biozentrum, Seminarraum U1.191 |
| Mittwoch 20.12.2023 | 15.15-17.00 Uhr | - Siehe Bemerkung, Examination weeks |
| Module |
Modul: Translating Pharmacology and Drug Safety to Humans (Masterstudium: Drug Sciences) Wahlbereich Master Pharmazie: Empfehlungen (Masterstudium: Pharmazie) |
| Leistungsüberprüfung | Lehrveranst.-begleitend |
| Hinweise zur Leistungsüberprüfung | Written examination at the end of the semester (multiple Choice, possibly some essay questions) https://pharma.unibas.ch/en/education/assessments-and-credit-points/continuous-assessments/ |
| An-/Abmeldung zur Leistungsüberprüfung | Anm.: Belegen Lehrveranstaltung; Abm.: stornieren |
| Wiederholungsprüfung | keine Wiederholungsprüfung |
| Skala | 1-6 0,5 |
| Wiederholtes Belegen | beliebig wiederholbar |
| Zuständige Fakultät | Philosophisch-Naturwissenschaftliche Fakultät, studiendekanat-philnat@unibas.ch |
| Anbietende Organisationseinheit | Departement Pharmazeutische Wissenschaften |