ADME and Drug-Drug Interaction Considerations During Drug Development
Published on 05-11-202211:34 AM by
qpham289| Updated on 05-11-202211:34 AM
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:
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
Brought to you by:
Dr. Pallavi Limaye Director of Scientific Consulting SEKISUI XenoTech