LFU:online

·        Understand the staggered development and the purpose of the clinical trial phases

• Know some detailed considerations about specific populations in clinical trials

·         Translation of preclinical results into clinical development strategies to establish inclusion and exclusion criteria to ensure subjects well being as absis for clinical trial development programme,

·         Translation of preclinical results into clinical development strategies to establish 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 woman;

·         Medical needs assessment for indication development decision

·         No-go and go-decision in clinical development.

Vorlesung (Computer-unterstützte visualisierte Präsentation, online Handouts)

schriftlich

Modules 1 and 2

2 UE self centered learning content