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

posted by Obinoscopy  – USA, 2018-04-24 13:00 (1278 d 15:06 ago) – Posting: # 18728
Views: 8,920

(edited by Obinoscopy on 2018-04-24 13:11)

» Yes, you need to calculate the f2 value regardless the GL's, as your Comparator didn't achieve a release of ≥85% at the time point 15 min.

How about if its the other way? That is:
If the dissolution values for the Comparator product were 32%, 63%, 88%, 91%, 95%, 96% and 97% respectively. And that of the Test product were 23%, 44%, 52%, 65%, 76%, 89% and 92% respectively.

Want to know what USFDA, EMA and WHO recommends in the above case scenario.

» How? as normal via the f2 equation

I actually did the calculation and got an f2 of 99.5. However the reason I wanted someone else to the calculation is to know the time points to use. I used time points of 5, 10, 15, 20, 25, 30 mins because the comparator product was able to achieve >85% dissolution at 30 mins. Wanted to know if I'm right.

Regards

Scopy

Complete thread:

Activity
 Admin contact
21,753 posts in 4,548 threads, 1,544 registered users;
online 16 (0 registered, 16 guests [including 5 identified bots]).
Forum time: Sunday 04:06 CEST (Europe/Vienna)

They were “so intent of making everything numerical”
that they frequently missed seeing
what was there to be seen.    Barbara McClintock

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