Bioequivalence and Bioavailability Forum • Sample after >85% release

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

posted by wienui – Germany/Oman, 2018-04-25 20:46 (2558 d 12:03 ago) – Posting: # 18730
Views: 12,104

Dear scopy,

❝ 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.

Here also you have to calculate the f2 factor as your test drug didn't achieve a release of ≥85% at the time point 15 min..

both test and reference products dissolve 85 percent or more of the label amount of the drug in 15 minutes

❝ Want to know what USFDA, EMA and WHO recommends in the above case scenario.

❝ 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.

Now comes the difference in the GL'S, in this case (your second case scenario) as Helmut mentioned above:

according to WHO your time points (till to 30 min.) included in the calculations of f2 are not correct as you have to add only one time point after reaching the 85% release for your reference drug, i.e only till 20 min.
but according to FDA & EMA you have to include the 45min time point too.

Regards,
Osama

—
Cheers,
Osama

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% releasewienui 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