f2 comparison [Dissolution / BCS / IVIVC]

posted by Vineeth KE – India, 2018-04-12 08:31 (1293 d 22:12 ago) – Posting: # 18667
Views: 3,767

Dear Jag009,

≫85% at the 2nd timepoint, do i still need to calculate f2

No need to calculate f2 value

» Please see below, at 2nd timepoint it's already ≫85%. I know that f2 is not required if release >85% within 15 mins but the lab only recorded release at 20 mins. It's safe to assume that >85% was probably achieved by 15 mins but i have no data to support.

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.

If the product dissolution is evaluating for the BCS Based bio-waiver, it is better to prove Rapid/very rapid dissolution by including time points such as 15 or 30 min.

As per USFDA guidance on BCS based Bio-waiver Dec 17, BCS Biowaiver USFDA Dec 2017

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.

Thank you.

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