Phase 1 clinical program planning is complicated these days with added pressure to get maximum study data and move quickly to Phase 2 or partner the clinical asset. This presentation will review the following specific study components which can be highly beneficial in terms of time and cost savings when included in a Phase 1/ First-in-Man clinical studies:

Metabolites in Safety Testing (MIST) in SAD/ MAD studies Concentration QT modeling (cQT modeling) in SAD studies Time and cost-effective Dose Selection strategy for SAD studies, bridging preclinical data to First-in-Man and beyond Register Now