Essential Considerations on the New FDA In Vitro DDI Guidance (the What, the Why, and the Wow)
Presenter: Brian Ogilvie, Ph.D., SEKISUI XenoTech Vice President of Scientific Consulting
In October, the FDA revised and split its 2012 draft guidance for industry on in vitro drug-drug interaction (DDI) studies, into one document for in vitro DDI studies, and another for clinical DDI studies. Dr. Brian Ogilvie will offer expert perspective on major changes to the in vitro guidance, whether they will impact your drug development strategy, and with more than two decades of experience in the area what SEKISUI XenoTech’s strategy is to address potential development challenges presented by the draft.
Key concepts discussed in this webinar will include:
- An overview of the major changes
- Are these recommendations or requirements?
- Views of the worldwide DDI guidance landscape
- Impacts on in vitro DDI study design and interpretation
- How SEKISUI XenoTech approaches developing effective strategies to ensure drug development programs are not delayed
- Considerations of whether to wait until the draft guidance is final, or to progress development of new drug candidates
- Why good science is always a trump card
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