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| Semester | fall semester 2022 |
| Course frequency | Every fall sem. |
| Lecturers | Mark Deurinck (mark.deurinck@unibas.ch, Assessor) |
| Content | 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 |
| Learning objectives | 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. |
| Bibliography | Provided during the lecture period |
| Comments | Film and sound recordings during the course are strictly forbidden (recorders may be confiscated) |
| Weblink | Department of Pharmaceutical Sciences |
| Admission requirements | Completed Bachelor degree |
| Course application | |
| Language of instruction | English |
| Use of digital media | No specific media used |
| Interval | Weekday | Time | Room |
|---|---|---|---|
| wöchentlich | Wednesday | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Date | Time | Room |
|---|---|---|
| Wednesday 21.09.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 28.09.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 05.10.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 12.10.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 19.10.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 26.10.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 02.11.2022 | 15.15-17.00 | Pharmazentrum, Examination weeks |
| Wednesday 09.11.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 16.11.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 23.11.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 30.11.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 07.12.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 14.12.2022 | 15.15-17.00 | Biozentrum, Seminarraum U1.191 |
| Wednesday 21.12.2022 | 15.15-17.00 | Pharmazentrum, Examination weeks |
| Modules |
Electives Master Science in Pharmacy: Recommendations (Master's Studies: Science in Pharmacy) Module: Translating Pharmacology and Drug Safety to Humans (Master's Studies: Drug Sciences) |
| Assessment format | continuous assessment |
| Assessment details | 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/ |
| Assessment registration/deregistration | Reg.: course registration, dereg: cancel course registration |
| Repeat examination | no repeat examination |
| Scale | 1-6 0,5 |
| Repeated registration | as often as necessary |
| Responsible faculty | Faculty of Science, studiendekanat-philnat@unibas.ch |
| Offered by | Departement Pharmazeutische Wissenschaften |