Important In Vitro Inhibition Study Design & Analysis Concerns

When evaluating drug-drug interaction (DDI) risk of an investigational drug, a battery of studies is needed to investigate victim/perpetrator potential. One of these comprises evaluation of the potential of a new therapy to inhibit drug-metabolizing enzymes, which can impact clearance of concomitantly administered drugs. The team at XenoTech has built a reputation of dedicating high-quality resources and specialists to conduct such studies with scientific rigor.

In this webinar, Jennifer Horkman, Study Director Team Supervisor in Metabolism Research at XenoTech, will address frequently asked questions from sponsors seeking inhibition studies and elaborate on some recommendations to achieve successful regulatory submission. Points of discussions will include an overview of enzyme inhibition studies and critical considerations in design, from determination of supporting data to conclusive interpretation.

The Q&A portion of this webinar will be led by Lois Haupt, Principal Scientist in Technical Advising at XenoTech. Both Jennifer and Lois have 20 years of DDI research experience at XenoTech and Lois’s 2015 paper on CYP inhibition is cited in the 2020 FDA final guidance, “In Vitro Drug Interaction Studies– Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.”

Key Learning Objectives:

• Why is measuring CYP inhibition important?
• FDA guidance requirements
• CYP inhibition study design
• Standard study considerations
• CYP inhibition decision tree
• IC50 determinations

Who Should Attend: Research scientists and drug development leadership aiming for successful IND / NDA submission, needing to meet regulatory requests and expectations, desiring to formulate a development plan that mitigates risks of late-stage failure, or simply wanting to better understand the ADME properties and potential DDI risks of their compound.