Comparison Between the Final US FDA, Japan PMDA, and EMA In Vitro DDI Guidance Documents: Are We Finally Harmonized?
Presenter: Brian Ogilvie, Ph.D., SEKISUI XenoTech Vice President of Scientific Consulting
In January, the FDA published its final guidance for industry on in vitro drug-drug interaction (DDI) studies. Dr. Ogilvie will offer his expert perspectives on major changes to the document, whether they will impact your drug development strategy, and with over 25 years of experience on the subject, what SEKISUI XenoTech’s strategy is to address potential development challenges presented by the final guidance. He will also compare it with the current EMA and PMDA in vitro guidance documents and discuss how to harmonize your drug development strategies to meet the expectations of all three.
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
- A comparison of each agency’s guidance documents
- A comparison of the equations and cutoff values
- A comparison of experimental details
- How to design studies to meet the expectations of each agency’s guidance documents
- Impacts on in vitro DDI study design and interpretation
- How SEKISUI XenoTech approaches developing effective strategies to ensure drug development programs are not delayed
- Why good science is always a trump card