f2 comparison [Dissolution / BCS / IVIVC]

posted by wienui  – Germany/Oman, 2018-04-12 12:14 (2494 d 05:59 ago) – Posting: # 18668
Views: 5,422

Dear Vineeth KE,

❝ It is not always mandatory to follow the particular time points such as (5, 10, 15, 20 ....etc) and moreover the time points are depends upon the release characteristics of the dosage form.


This is correct

when both test and reference products dissolve 85 percent or more of the label amount of the drug in 15 minutes using all three dissolution media recommended above, the profile comparison with an f2 test is unnecessary.


This is also correct, but from the above given data, release % at time point 15min. was not given, There is no evidence that 85% release at 15min, it could be and it couldn't be ( as Example, it could be only release of 64%, 76%, 82%).
Therefore, a calculation of F2 is needed.

Best regards,
Osama

Cheers,
Osama

Complete thread:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,667 registered users;
208 visitors (0 registered, 208 guests [including 17 identified bots]).
Forum time: 17:14 CET (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

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