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23818-01 - Lecture: Safety Assessment for First-in-Human Clinical Trials (2 CP)
| Semester | spring semester 2025 |
| Course frequency | Every spring sem. |
| Lecturers |
Patrick Yves Müller (y.mueller@unibas.ch)
Alex Odermatt (alex.odermatt@unibas.ch, Assessor) |
| Content | The objective of this new lecture series is to cover safety assessment and ADMET strategies required to advance low molecular weight drug candidates and therapeutic monoclonal antibodies "from bench to bedside". The focus is on toxicology/safety/ADMET approaches leading to first human entry (clinical phase I) including selection of the first human dose. State of the art drug development strategies aiming at clinical entry are exemplified by representatives from the pharmaceutical industry and from academia by including interactive case studies. Week 1: Safety assessment: introduction to early drug development; Target selectivity and drug candidate selectivity; Anti-Target screening Week 2: DMPK & ADME assessment; Toxicity / Safety biomarkers; Safety pharmacology. Week 3: Safety assessment: MedChem parameters, formulations & CYP inhibition; On-Target toxicity - off-target safety profiling; In vivo toxicology; Qualification of preclinical safety findings. Week 4: Safety endpoints in later development; Safety considerations for biotechnology-derived pharmaceuticals; Dose selections for first-human entry: general concepts, NMEs. Week 5: Special considerations for biotechnology-derived pharmaceuticals ; Dose selections for first human entry: mAbs, MABEL ; Immunogenicity of biologics; Regulatory considerations for first-in-human trials. Week 6: Exam |
| Learning objectives | - to know the toxicological and safety pharmacological ADME studies and end points and to understand the reasons why they are necessary in order to test a drug for the first time in human - to know differences between low molecular weight drugs and therapeutic antibodies with respect to preclinical toxicology and early clinical development - to know the relevance and methods in the assessment of drug selectivity - to understand qualitative and quantitative estimates of toxicological parameters with respect to first in human dose - to understand the principles of design and safety/toxicity end points of phase I studies |
| 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 |
| Language of instruction | English |
| Use of digital media | No specific media used |
| Course auditors welcome |
| Interval | Weekday | Time | Room |
|---|---|---|---|
| wöchentlich | Friday | 08.15-12.00 | Pharmazentrum, Hörsaal 2 |
Dates
| Date | Time | Room |
|---|---|---|
| Friday 21.02.2025 | 08.15-09.00 | Pharmazentrum, Hörsaal 2 |
| Friday 21.02.2025 | 09.15-10.00 | Pharmazentrum, Hörsaal 2 |
| Friday 21.02.2025 | 10.15-11.00 | Pharmazentrum, Hörsaal 2 |
| Friday 21.02.2025 | 11.15-12.00 | Pharmazentrum, Hörsaal 2 |
| Friday 28.02.2025 | 08.15-09.00 | Pharmazentrum, Hörsaal 2 |
| Friday 28.02.2025 | 09.15-10.00 | Pharmazentrum, Hörsaal 2 |
| Friday 28.02.2025 | 10.15-11.00 | Pharmazentrum, Hörsaal 2 |
| Friday 28.02.2025 | 11.15-12.00 | Pharmazentrum, Hörsaal 2 |
| Friday 07.03.2025 | 08.15-09.00 | Pharmazentrum, Hörsaal 2 |
| Friday 07.03.2025 | 09.15-10.00 | Pharmazentrum, Hörsaal 2 |
| Friday 07.03.2025 | 10.15-11.00 | Pharmazentrum, Hörsaal 2 |
| Friday 07.03.2025 | 11.15-12.00 | Pharmazentrum, Hörsaal 2 |
| Friday 14.03.2025 | 08.15-12.00 | Fasnachstferien |
| Friday 21.03.2025 | 08.15-09.00 | Pharmazentrum, Hörsaal 2 |
| Friday 21.03.2025 | 09.15-10.00 | Pharmazentrum, Hörsaal 2 |
| Friday 21.03.2025 | 10.15-11.00 | Pharmazentrum, Hörsaal 2 |
| Friday 21.03.2025 | 11.15-12.00 | Pharmazentrum, Hörsaal 2 |
| Friday 28.03.2025 | 08.15-09.00 | Pharmazentrum, Hörsaal 2 |
| Friday 28.03.2025 | 09.15-10.00 | Pharmazentrum, Hörsaal 2 |
| Friday 28.03.2025 | 10.15-11.00 | Pharmazentrum, Hörsaal 2 |
| Friday 28.03.2025 | 11.15-12.00 | Pharmazentrum, Hörsaal 2 |
| Thursday 24.04.2025 | 08.45-09.45 | Biozentrum, Hörsaal U1.101 |
| Modules |
Electives Master Science in Pharmacy: Recommendations (Master's Studies: Science in Pharmacy) Module Specialisation: Medical Nanosciences (Master's Studies: Nanosciences) Module: Translating Pharmacology and Drug Safety to Humans (Master's Studies: Drug Sciences) |
| Assessment format | continuous assessment |
| Assessment details | Please refer to the list: 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 |