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RegisterSample after >85% release [Dissolution / BCS / IVIVC]
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.
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.
Regards
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.
Regards
—
Scopy
Scopy
Complete thread:
- f2 Calculation For Rapidly Dissolving FPPs Obinoscopy 2018-04-22 15:11 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sample after >85% release Helmut 2018-04-22 16:56
- Sample after >85% release wienui 2018-04-22 21:39
- Sample after >85% release Obinoscopy 2018-04-23 00:53
- Sample after >85% release wienui 2018-04-23 03:32
- Sample after >85% release Obinoscopy 2018-04-24 13:00
- Sample after >85% release wienui 2018-04-25 18:46
- Sample after >85% release Obinoscopy 2018-04-27 02:51
- Sample after >85% release wienui 2018-04-27 03:23
- Sample after >85% releaseObinoscopy 2018-04-28 20:30
- Sample after >85% release Helmut 2018-04-29 13:53
- Sample after >85% release Obinoscopy 2018-04-29 22:08
- Sample after >85% release Helmut 2018-04-29 13:53
- Sample after >85% releaseObinoscopy 2018-04-28 20:30
- Sample after >85% release wienui 2018-04-27 03:23
- Sample after >85% release Obinoscopy 2018-04-27 02:51
- Sample after >85% release wienui 2018-04-25 18:46
- Sample after >85% release Obinoscopy 2018-04-24 13:00
- Sample after >85% release wienui 2018-04-23 03:32
- FPP Ohlbe 2018-04-23 11:10
- Sample after >85% release Helmut 2018-04-22 16:56
Ing. Helmut Schütz