f2 comparison [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2018-04-10 17:58 (2238 d 08:45 ago) – Posting: # 18662
Views: 5,362

Hi,
A question... If two products achieve release ≫85% at the 2nd timepoint, do i still need to calculate f2 since f2 requires a minimum of 3 points and only 1 value above 85% can be included?
Please see below, at 2nd timepoint it's already ≫85%. I know that f2 is not required if release >85% within 15 mins but the lab only recorded release at 20 mins. It's safe to assume that >85% was probably achieved by 15 mins but i have no data to support.

Test at 10 mins=42%, at 20 mins=92%, at 30 mins=97%
RLD at 10 mins=43%, at 20 mins=92%, at 30 mins=98%

Thanks
J

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