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

posted by Obinoscopy  – USA, 2018-04-24 13:00 (1321 d 12:09 ago) – Posting: # 18728
Views: 9,012

(edited by Obinoscopy on 2018-04-24 13:11)

» 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 about if its the other way? That is:
If the dissolution values for the Comparator product were 32%, 63%, 88%, 91%, 95%, 96% and 97% respectively. And that of the Test product were 23%, 44%, 52%, 65%, 76%, 89% and 92% respectively.

Want to know what USFDA, EMA and WHO recommends in the above case scenario.

» How? as normal via the f2 equation

I actually did the calculation and got an f2 of 99.5. However the reason I wanted someone else to the calculation is to know the time points to use. I used time points of 5, 10, 15, 20, 25, 30 mins because the comparator product was able to achieve >85% dissolution at 30 mins. Wanted to know if I'm right.



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