2020

Comparison Between the Final US FDA (2020), Japan PMDA (2018) and EMA (2013) In Vitro DDI Guidance

Published:  24 February 2020

Comparison Between the Final US FDA (2020), the Final Japan PMDA (2018), and Final EMA (2013) In Vitro DDI Guidance Documents: Are We Finally Harmonized?

Brian W. Ogilvie1 and Andrew Parkinson2
1Sekisui XenoTech, LLC, Kansas City, KS, USA and 2XPD Consulting, Shawnee, KS, USA

Abstract:
In January, 2020, the US FDA finalized its 2017 draft guidance documents for industry on in vitro and clinical (DDI) studies. In February 2018, the Japan PMDA finalized its draft 2017 DDI guideline, with an official English version published in 2019. The EMA guideline has not been revised since 2013. An overview of the major changes from the draft to final in vitro FDA DDI guidance, a comparison of each agency’s equations and cut-off values, and a comparison of certain experimental details will be highlighted. This poster will also highlight strategies to harmonize the design of in vitro DDI studies to meet the expectations of all three agencies.