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

posted by Obinoscopy  – USA, 2018-04-28 20:30 (1564 d 01:14 ago) – Posting: # 18739
Views: 9,185

Dear Osama,

Thanks so much for your assistance.

Regarding your last post, I had a different understanding of the last time point to use when calculating for f2.

» 1 time point have to be added in the calculation of f2 after reaching the 85% releasing time point, i.e
» WHO: 20 min
» EMA & FDA: 45

I had thought the next time point after achieving 85% release (or time point at asymptote) should be used.

For reference product, exactly 85% release was achieved at a timepoint in between 10 and 15mins (even though this timepoint was not measured) thus the closest measured timepoint of 15mins should be the additional timepoint after 85% release has been achieved (ie >85% release will achieved at that timepoint).

Similarly, for the test product, exactly 85% release will be achieved at a timepoint in between 25 and 30mins. Thus the minimal timepoint when greater than 85% was achieved becomes 30 mins.

I had to read the guidelines over again and I couldn't find anything wrong with my mine. But I also couldn't disprove yours either. Perhaps Ohlbe, Helmut as well as others could weigh in their thoughts on this.



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