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23818-01 - Vorlesung: Safety Assessment for First-in-Human Clinical Trials (2 KP)
| Semester | Frühjahrsemester 2025 |
| Angebotsmuster | Jedes Frühjahrsem. |
| Dozierende |
Patrick Yves Müller (y.mueller@unibas.ch)
Alex Odermatt (alex.odermatt@unibas.ch, BeurteilerIn) |
| Inhalt | 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 |
| Lernziele | - 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 |
| Bemerkungen | Film and sound recordings during the course are strictly forbidden (recorders may be confiscated |
| Weblink | Department of Pharmaceutical Sciences |
| Teilnahmevoraussetzungen | Completed Bachelor degree |
| Unterrichtssprache | Englisch |
| Einsatz digitaler Medien | kein spezifischer Einsatz |
| HörerInnen willkommen |
| Intervall | Wochentag | Zeit | Raum |
|---|---|---|---|
| wöchentlich | Freitag | 08.15-12.00 | Pharmazentrum, Hörsaal 2 |
Einzeltermine
| Datum | Zeit | Raum |
|---|---|---|
| Freitag 21.02.2025 | 08.15-12.00 Uhr | Pharmazentrum, Hörsaal 2 |
| Freitag 28.02.2025 | 08.15-12.00 Uhr | Pharmazentrum, Hörsaal 2 |
| Freitag 07.03.2025 | 08.15-12.00 Uhr | Pharmazentrum, Hörsaal 2 |
| Freitag 14.03.2025 | 08.15-12.00 Uhr | Fasnachstferien |
| Freitag 21.03.2025 | 08.15-12.00 Uhr | Pharmazentrum, Hörsaal 2 |
| Freitag 28.03.2025 | 08.15-12.00 Uhr | Pharmazentrum, Hörsaal 2 |
| Freitag 04.04.2025 | 08.15-12.00 Uhr | Pharmazentrum, Hörsaal 2 |
| Freitag 11.04.2025 | 08.15-12.00 Uhr | Pharmazentrum, Hörsaal 2 |
| Donnerstag 24.04.2025 | 08.45-09.45 Uhr | Biozentrum, Hörsaal U1.101 |
| Module |
Modul: Translating Pharmacology and Drug Safety to Humans (Masterstudium: Drug Sciences) Modul: Vertiefung Medizinische Nanowissenschaften (Masterstudium: Nanowissenschaften) Wahlbereich Master Pharmazie: Empfehlungen (Masterstudium: Pharmazie) |
| Prüfung | Lehrveranst.-begleitend |
| Hinweise zur Prüfung | Please refer to the list: https://pharma.unibas.ch/en/education/assessments-and-credit-points/continuous-assessments/ |
| An-/Abmeldung zur Prüfung | Anm.: Belegen Lehrveranstaltung; Abm.: stornieren |
| Wiederholungsprüfung | keine Wiederholungsprüfung |
| Skala | 1-6 0,5 |
| Belegen bei Nichtbestehen | beliebig wiederholbar |
| Zuständige Fakultät | Philosophisch-Naturwissenschaftliche Fakultät, studiendekanat-philnat@unibas.ch |
| Anbietende Organisationseinheit | Departement Pharmazeutische Wissenschaften |