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

posted by Obinoscopy  – USA, 2018-04-29 22:08 (1318 d 14:19 ago) – Posting: # 18742
Views: 8,831

(edited by Obinoscopy on 2018-04-29 22:30)

Hi Helmut,

I'm glad seeing your response.

» FDA (1st time >85% for T at 30 min, one sample after at 45 min): ƒ1 21.53, ƒ2 34.73
» FDA (1st time >85% for T at 28.46 min, one sample after at 30 min): ƒ1 24.95, ƒ2 33.16
» WHO (1st time >85% for R at 15 min, one sample after at 20 min): ƒ1 32.85, ƒ2 30.47
» WHO (1st time >85% for R at 14.40 min, one sample after at 15 min): ƒ1 34.97, ƒ2 30.19

I noticed you used two case scenarios when calculating for f1 and f2. Is it that the guidelines are very specific as to the last timepoint to use when calculating for f1 and f2?

I had thought the last time point to use in f1 and f2 calculation should be the timepoint when more than 85% dissolution has been achieved.

Also if the values were switched between Test and Reference, what will be the decision to take using both FDA and WHO guidelines? I'm guessing both FDA and WHO will use the timepoint 30 minutes (ƒ1 24.95, ƒ2 33.16).

» Can you elaborate how you arrived in this post at an ƒ2 of 99.5? Just by looking at the curves such a high ƒ2 does not seem to be possible.

Seen your calculation. Now I know where I got it wrong. I transformed the percentages to decimals (ie 23% to 0.23) before doing the calculations which is wrong. Thanks.



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