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23818-01 - Vorlesung: Safety Assessment for First-in-Human Clinical Trials 2 KP

Semester Frühjahrsemester 2021
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:
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


Teilnahmebedingungen Completed Bachelor degree
Unterrichtssprache Englisch
Einsatz digitaler Medien kein spezifischer Einsatz
HörerInnen willkommen


Intervall wöchentlich
Datum 05.03.2021 – 09.04.2021
Zeit Freitag, 08.15-12.00 - Online Präsenz -
Datum Zeit Raum
Freitag 05.03.2021 08.15-12.00 Uhr --, --
Freitag 12.03.2021 08.15-12.00 Uhr --, --
Freitag 19.03.2021 08.15-12.00 Uhr --, --
Freitag 26.03.2021 08.15-12.00 Uhr --, --
Freitag 02.04.2021 08.15-12.00 Uhr Ostern
Freitag 09.04.2021 08.15-12.00 Uhr --, --
Module Modul: Translating Pharmacology and Drug Safety to Humans (Masterstudium: Drug Sciences)
Wahlbereich Master Pharmazie: Empfehlungen (Masterstudium: Pharmazie)
Leistungsüberprüfung Lehrveranst.-begleitend
Hinweise zur Leistungsüberprüfung Please refer to the list:
An-/Abmeldung zur Leistungsüberprüfung An-/Abmelden: Belegen resp. Stornieren der Belegung via MOnA
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