Sample after >85% release [Dissolution / BCS / IVIVC]
❝ 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.
Regards
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Scopy
Scopy
Complete thread:
- f2 Calculation For Rapidly Dissolving FPPs Obinoscopy 2018-04-22 15:11 [Dissolution / BCS / IVIVC]
- 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% releaseObinoscopy 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% release Obinoscopy 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% release Obinoscopy 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% releaseObinoscopy 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