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

posted by Obinoscopy  – USA, 2018-04-27 02:51 (1318 d 22:59 ago) – Posting: # 18735
Views: 8,928

» 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

Awesome. Thanks!

» Now comes the difference in the GL'S, in this case ( your second case scenario) as Helmut mentioned above:
» – according to WHO your time points (till to 30 min.) included in the calculations of f2 are not correct as you have to add only one time point after reaching the 85% release for your reference drug, i.e only till 20 min.
» – but according to FDA & EMA you have to include the 45min time point too.

For the second scenario, I thought it should be till 15 mins for WHO and till 30 mins for FDA and EMA. This because the time point for the comparator at 15 mins was 88% while the time point for the test product at 30 mins was 89%. These were the points when >85% was first achieved. Please confirm if I'm right.

Thanks so much for your time. I appreciate.



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