Bioequivalence and Bioavailability Forum • EU: Fed state according to the reference’s SmPC

EU: Fed state according to the reference’s SmPC [Design Issues]

posted by Helmut – Vienna, Austria, 2021-09-24 18:07 (1217 d 17:46 ago) – Posting: # 22596
Views: 2,524

Hi BR,

❝ 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

Nevertheless, some (or most?) agencies may ask you for studies vs the mono-components (if marketed). See this post.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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EU: Fed or fasting conditions for BE study Farmacevt 2021-09-24 15:47 [Design Issues]
- EU: Fed state according to the reference’s SmPCHelmut 2021-09-24 16:07
  - EU: Fed state according to the reference’s SmPC Farmacevt 2021-09-27 21:44