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| Semester | fall semester 2018 |
| Course frequency | Every fall sem. |
| Lecturers | Ester Lovsin (ester.lovsin@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. Lecturers will be joining us from the acrtoss the industry and academia. Week 1: I. Principles, Regulations, Ethics Animal Experimentation for Regulatory Purposes Ester Lovsin Barle Species-specific Effects in Toxicity Gian C. Winkler Week 2: Ethics in Animal experimentation Maike Heimann Week 3: Regulations for conducting animal experiments Walter Zeller Week 4: Regulatory toxicology Friedlib Pfankuch Week 5: II. Preclinical Study Endpoints Toxicology Vicente Nogues Week 6: Mode of action and biological targets Thomas Pfister Week 7: Haematology, Clinical Chemistry, Urinalysis Hans Winkler Week 8: Safety Pharmacology (telemetry in dogs) Mark Deurinck Week 9: III. Application In vivo Genotoxicity Hansjörg Martus Week 10: Carcinogenicity studies Ursula Junker Walker Week 11: Reproductive Toxicology Rudolf Bechter Week 12: Risk Assessment for Occupational Health Ester Lovsin Barle Week 13: Risk assessment for patient safety in manufacturing Thomas Pfister Week 14: Examination Additional: Jan.: Visit Novartis NIBR Research animal facility (to be confirmed) |
| 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 hazard assessment. |
| Bibliography | Provided during the lecture period |
| Comments | Film and sound recordings during the course are strictly forbidden (recorders may be confiscated) |
| Weblink | ADAM |
| Course application | |
| Language of instruction | English |
| Use of digital media | No specific media used |
| Interval | Weekday | Time | Room |
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No dates available. Please contact the lecturer.
| 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/de/teaching/pruefungen-exams/performance-assessments/course-accompanying-examinations/ |
| 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 |