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

posted by wienui  – Germany/Oman, 2018-04-23 03:32 (1487 d 17:14 ago) – Posting: # 18722
Views: 9,431

Dear Scopy,

» If the 5, 10, 15, 20, 25, 30 and 45 mins dissolution values for the test product were 32%, 63%, 88%, 91%, 95%, 96% and 97% respectively. And that of the Comparator were 23%, 44%, 52%, 65%, 76%, 89% and 92% respectively.
»
» Is f2 calculation required going by USFDA, EMA and WHO GLs? If it is, how's the calculation done?

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? as normal via the f2 equation, please have a look here https://www.fda.gov/downloads/drugs/guidances/ucm070237.pdf

Regards,
Osama

Cheers,
Osama

Complete thread:

UA Flag
Activity
 Admin contact
22,085 posts in 4,629 threads, 1,566 registered users;
online 17 (0 registered, 17 guests [including 16 identified bots]).
Forum time: Thursday 20:47 CEST (Europe/Vienna)

That which is not controversial
is of no particular interest.    Johann Wolfgang von Goethe

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