f2 comparison [Dissolution / BCS / IVIVC]

posted by wienui  – Germany, Oman, 2018-04-12 10:14 (1290 d 18:37 ago) – Posting: # 18668
Views: 3,746

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

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