Current In Vitro DDI Regulatory Guidance (Reference Poster)
Presented at the Marbach Castle Drug-Drug Interaction Workshop in Germany
In September, 2017, the Japan PMDA revised its 2014 guideline and released it for comments. In October, 2017, the US FDA revised and split its 2012 draft guidance for industry on in vitro drug-drug interaction (DDI) studies, into one document for in vitro DDI studies, and another for clinical DDI studies. An overview of the major changes, a comparison of each agency’s equations and cut-off values (including the most recently released 2013 EMA DDI guidelines), and a comparison of 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 both agencies.