Biowaiver for lower strength using different OGD media [Dissolution / BCS / IVIVC]

posted by dshah  – India/United Kingdom, 2020-07-13 10:09 (1062 d 13:08 ago) – Posting: # 21680
Views: 3,076

Greetings All!
Hope all are doing well and are safe in this pandemic condition.
We are working on a NTI drug with high variability for which different dissolution media is recommended by USFDA.
For BE study as per USFDA- a fasting and fed study for highest strength is recommended.
For EMA- A fed study on highest strength and a fasting study on another mid strength is concluded based on guideline.
For waiver request for other strength we need acceptable in vitro dissolution testing of all strengths. Generally media for lower and higher strength are same but in my condition, due to solubility limitations, highest strength's dissolution is recommended with 0.45% SDS, a mid range strength's dissolution with 0.2% SDS and lower strength dissolution using no surfactant are recommended.
A screenshot is attached for reference. [image]
In such condition- how to prove F2 value>50 for rest of the strength because recommended media are different?
Regards,
Shah

Complete thread:

UA Flag
Activity
 Admin contact
22,627 posts in 4,743 threads, 1,613 registered users;
32 visitors (0 registered, 32 guests [including 19 identified bots]).
Forum time: 23:17 CEST (Europe/Vienna)

Learn the rules like a pro,
so you can break them like an artist.    attributed to Pablo Picasso

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5