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New Drug-Drug Interaction Regulatory Guidance Updates

from Sekisui XenoTech

The following webinars on the new 2017 US FDA, Japan PMDA as well as upcoming European EMA DDI guidance updates are available:

Sekisui XenoTech Webinar: Essential Considerations on the New FDA In Vitro DDI Guidance (the What, the Why, and the Wow)
Aired: 11/21/2017
Presenter: Brian Ogilvie, Ph.D., Sekisui XenoTech Vice President of Scientific Consulting

Comparison Between the New US FDA and Japan PMDA In Vitro DDI Guidance Documents: Are We Close to Harmonization?
Aired: 19 December 2017
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 In October, the US FDA revised and split its 2012 draft guidance for industry on in vitro drug-drug interaction (DDI) studies, into one document for in vitro DDI studies, and another for clinical DDI studies.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, 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 these webinars include:
- An overview of the major changes and comparison of each agency’s guidance documents
- Are these recommendations or requirements?
- Views of the worldwide DDI guidance landscape
- Impacts on in vitro DDI study design and interpretation
- 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
- 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- Considerations of whether to wait until the draft guidance is final, or to progress development of new drug candidates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

Register to view the full webinars, download the slides and guidance documents, access other past webinars or register for future webinars, and much more at: https://www.xenotech.com/scientific-resources?418TN

about 3 months ago

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Sekisui XenoTech
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