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

posted by wienui  – Germany, Oman, 2018-04-23 03:32 (1280 d 01:12 ago) – Posting: # 18722
Views: 9,090

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

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