Amoxicillin/clavulanic acid: if possible, avoid fasting state [Design Issues]
Hi Amira!
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):
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).
❝ […] 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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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Bioequivalence study conditions Amira Gouda 2018-06-03 16:30
- Amoxicillin/clavulanic acid: if possible, avoid fasting stateHelmut 2018-06-03 19:47