In Vitro Inhibition Studies: Elements of Design and Important Considerations in Data Analysis
Presenter: Jennifer Horkman, Senior Scientist in Program Oversight at SEKISUI XenoTech
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 SEKISUI XenoTech has built a reputation of dedicating high-quality resources and specialists to conduct such studies with scientific rigor.
In this webinar, Jennifer will address frequently asked questions from sponsors seeking inhibition studies and elaborate on some recommendations we give 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.
Key concepts discussed in this webinar will include:
- Why is measuring CYP inhibition important?
- Terminology for enzyme kinetics
- FDA guidance requirements
- CYP inhibition study design
- Types of enzyme inhibition
- Standard study considerations
- CYP inhibition decision tree
- IC50 determinations
About the presenter: Jennifer Horkman has more than 15 years of experience at SEKISUI XenoTech. First joining the company in a customer service role, Jenny moved into test system production, specializing in hepatocyte isolation and cryopreservation; and then into conducting enzyme inhibition studies. She is now a Senior Scientist in our Program Oversight department, serving as scientific reviewer and Study Director of multiple nonclinical, drug interaction-related contract studies across multiple disciplines in compliance with Good Laboratory Practices (GLP), The Organisation for Economic Co-operation and Development (OECD) Principles of GLP, and/or Japan Ministry of Health and Welfare (MOHW) GLP Standards.