Sample after >85% release [Dissolution / BCS / IVIVC]

posted by wienui  – Germany/Oman, 2018-04-27 03:23 (1565 d 19:40 ago) – Posting: # 18736
Views: 9,310

Dear Scopy,

» For the second scenario, I thought it should be till 15 mins for WHO and till 30 mins for FDA and EMA. This because the time point for the comparator at 15 mins was 88% while the time point for the test product at 30 mins was 89%. These were the points when >85% was first achieved. Please confirm if I'm right.

1 time point have to be added in the calculation of f2 after reaching the 85% releasing time point, i.e
WHO: 20 min
EMA & FDA: 45

Regards,
Osama

Cheers,
Osama

Complete thread:

UA Flag
Activity
 Admin contact
22,289 posts in 4,666 threads, 1,585 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Tuesday 23:03 CEST (Europe/Vienna)

The existing scientific concepts cover always only
a very limited part of reality,
and the other part that has not yet
been understood is infinite.    Werner Heisenberg

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