EU: Fed state according to the reference’s SmPC [Design Issues]
❝ What is the most appropriate condition for performing the BE study in this situation, fed or fasting ?
IMHO, in fed state. Justification:
- The product-specific GL is not for a FDC and in general fasting is preferred. However, there is no food effect of the first mono-component.
- Even if you would perform a study of the second component alone, according to the BE-GL it would have to be in fed state, since required in the reference’s SmPC. You don’t want to make the subjects
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