In Vitro Induction Studies: Elements of Design and Important Considerations in Data Analysis
Presenter: Joanna Barbara, Ph.D., Vice President of Scientific Operations at SEKISUI XenoTech
Synopsis: 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 induce 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, Dr. Joanna Barbara will address frequently asked questions from sponsors seeking induction studies and elaborate on some recommendations we give to achieve successful regulatory submission. Points of discussions will include an overview of enzyme induction studies and critical considerations in design, from determination of supporting data to conclusive interpretation.
Key concepts discussed in this webinar will include:
- Standard study considerations
- FDA guidance requirements
- Required endpoints for IND submission
- 3A induction and associated challenges
- Next-step recommendations