Comparison Between the Final FDA, PMDA, and EMA In Vitro Drug Interaction Guidance

Expert drug-drug interaction (DDI) insights into potential development challenges presented by the current in vitro guidance documents and how to harmonize your strategies to meet the expectations of all three.

Key concepts discussed in this webinar & reference poster include:

  • Overview of the worldwide DDI guidance landscape
  • Impacts on in vitro DDI study design and interpretation
  • Are these recommendations or requirements?
  • Comparison of each agency’s guidance documents
  • Comparison of the equations, cutoff values & experimental details
  • Designing studies to meet the expectations of each agency’s guidance documents
  • Developing effective strategies to ensure drug development programs are not delayed

Watch the Presentation & Download the Poster Here.

 

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