Comparison Between the US FDA, EU EMA and Japan PMDA In Vitro DDI Guidance Documents: Are We Close to Harmonization?
Co-Presenters: Brian Ogilvie, Ph.D., SEKISUI XenoTech Vice President of Scientific Consulting, and Andrew Parkinson, Ph.D., XPD Consulting Chief Executive Officer
In September, the Japan PMDA revised its 2014 guideline and released it (only in Japanese) for comments. In October, the US FDA revised and split its 2012 draft guidance for industry on in vitro drug-drug interaction (DDI) studies, into one document for in vitro DDI studies, and another for clinical DDI studies. Drs. Andrew Parkinson, XPD Consulting, and Brian Ogilvie, SEKISUI XenoTech, will offer their expert perspectives on major changes and differences between the two agencies’ in vitro guidance documents, and how to harmonize your drug development strategies to meet the expectations of both.
Key concepts discussed in this webinar will include:
- An overview of the major changes and comparison of FDA and PMDA 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
Register below to request access to the slides and recording of the webinar as well as the English-translated PMDA guideline document. Our convenient and informative reference poster is also available for download.
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