Bioequivalence and Bioavailability Forum • Sample after >85% release

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

posted by Obinoscopy – USA, 2018-04-24 15:00 (2187 d 05:20 ago) – Posting: # 18728
Views: 10,564

❝ 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

—
Scopy

Complete thread:

f2 Calculation For Rapidly Dissolving FPPs Obinoscopy 2018-04-22 15:11
- 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
  - FPP Ohlbe 2018-04-23 11:10
    - FPP Helmut 2018-04-24 00:24
      - FPP JMCardot 2018-05-19 10:12