Posting: # 18845
Could you please advice me if the BE study for amoxicillin/clavulanic acid is done under fast or fed conditions with references please??
Thanks in advance
Edit: Category changed; see also this post #1. [Helmut]
@ Amira Gouda
Posting: # 18849
» […] if the BE study for amoxicillin/clavulanic acid is done under fast or fed conditions with references please??
Please do you homework first (see also this post #3).
The FDA requires two studies (fasting & fed). IMHO, that’s not a good approach because you might face a lot of nasty GI-related AEs in fasting state.
IMHO, the EMA’s GL is better (Section 4.1.1):
For products where the SmPC recommends intake of the reference medicinal product only in fed state, the bioequivalence study should generally be conducted under fed conditions.The SmPC:
Augmentin should be administered with a meal to minimise potential gastrointestinal intolerance.
In our studies we didn’t serve a high-fat high-calory meal but a light breakfast as a compromise (since fasting is considered more discriminatory).
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