f2 comparison [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2018-04-10 17:58 (1996 d 06:47 ago) – Posting: # 18662
Views: 4,885

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%


Complete thread:

UA Flag
 Admin contact
22,761 posts in 4,775 threads, 1,628 registered users;
14 visitors (0 registered, 14 guests [including 7 identified bots]).
Forum time: 00:46 CEST (Europe/Vienna)

Medical researches can be divided into two sorts:
those who think that meta is better and those
who believe that pooling is fooling.    Stephen Senn

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