In vitro ADME and drug-drug interaction (DDI) investigations are early activities in the drug development process that are critical for framing downstream decision making. This webinar will provide insights at a high-level related to regulatory drivers, investigatory objectives, and practical concerns for such studies.
Participants will gain insight into the critical need and utility for in vitro ADME and DDI investigations in the drug development process. Regulatory expectations will be reviewed as will points of particular interest for enabling successful achievement of investigatory goals.
Key Learning Objectives:
- Why run these studies?
- Predominant types of in vitro ADME & DDI studies
- When to conduct these studies
- Areas of concern: Proper design & interpretation
- And other highlights and information…
Who Should Attend:
- Research scientists
- Drug development leadership
- Anyone aiming for successful IND / NDA submission
- Needing to meet regulatory requests and expectations
- Desiring to formulate a development plan that is as efficient and cost-effective as possible and mitigates risks of late stage failure
- Simply wanting to better understand the ADME properties and potential DDI risks of their compound