Dear Sakeni,
I assume the API in question is either BCA Class 1 or Class 3. If that is the case, then I would refer to the clear guidelines outlined in ICH M9, where you will find that demonstration of rapid dissolution at the three different pH values is a requirement to claim a biowaiver.
Hope this helps,
Maurizio
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Maurizio Franzini
Regulatory Affairs CMC, Director
San Francisco CA
United States
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Original Message:
Sent: 12-May-2022 03:38
From: Sakeni Hadebe
Subject: Similarity of dissolution profiles
Dear Colleagues
As a BE assessor I have come across issues where the applicant is unable to demonstrate similarity between a Biobatch and a lower strength at pH 1.2 and 4.5 citing API related issues. Similarity was only demonstrated at pH 6.8 only. what is your view with regards to granting of additional strength biowaiver considering that similarity was only demonstrated at pH 6.8.??.
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SAKENI HADEBE
Pharmacist
LUSAKA
Zambia
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