LFU:online

Translation of preclinical results into clinical development strategies up to the first application in humans; assessment of medical need; gender-specific aspects

• Translation of preclinical results into clinical development strategies to establish inclusion and exclusion criteria to ensure subjects well being as basis for a clinical trial development programme and to establish a potential indication
• Phases of clinical trials
• Non-clinical bioavailability (PK/PD aspects) for first in human dose and therapeutic interval
• Aspects affecting early clinical drug development in special populations like elderly or paediatrics and in reproduction age in man or women of childbearing potential or pregnant women
• Medical needs assessment for indication development decision, no-go and go-decision in clinical development

Lecture with interactive elements involving student participation, audience response systems, online handouts

written exam

Modules 1 and 2