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

posted by wienui  – Germany/Oman, 2018-04-25 18:46 (1574 d 23:14 ago) – Posting: # 18730
Views: 9,291

Dear scopy,

» 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.

Here also you have to calculate the f2 factor as your test drug didn't achieve a release of ≥85% at the time point 15 min..

both test and reference products dissolve 85 percent or more of the label amount of the drug in 15 minutes

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

» 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.

Now comes the difference in the GL'S, in this case (your second case scenario) as Helmut mentioned above:
Regards,
Osama

Cheers,
Osama

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