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

Hi Helmut,

I'm glad seeing your response.

» FDA (1

» FDA (1

» WHO (1

» WHO (1

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 (ƒ

» Can you elaborate how you arrived in this post at an ƒ

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.

Regards,

I'm glad seeing your response.

» FDA (1

^{st}time >85% for T at 30 min, one sample after at 45 min): ƒ_{1}21.53, ƒ_{2}34.73» FDA (1

^{st}time >85% for T at 28.46 min, one sample after at 30 min): ƒ_{1}24.95, ƒ_{2}33.16» WHO (1

^{st}time >85% for R at 15 min, one sample after at 20 min): ƒ_{1}32.85, ƒ_{2}30.47» WHO (1

^{st}time >85% for R at 14.40 min, one sample after at 15 min): ƒ_{1}34.97, ƒ_{2}30.19I 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 (ƒ

_{1}24.95, ƒ_{2}33.16).» Can you elaborate how you arrived in this post at an ƒ

_{2}of 99.5? Just by*looking*at the curves such a high ƒ_{2}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.

Regards,

—

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% 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% release Obinoscopy 2018-04-28 20:30
- Sample after >85% release Helmut 2018-04-29 13:53
- Sample after >85% releaseObinoscopy 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% 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