Bioequivalence and Bioavailability Forum • Sample after >85% release

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

posted by wienui – Germany/Oman, 2018-04-27 05:23 (2557 d 02:55 ago) – Posting: # 18736
Views: 12,098

Dear Scopy,

❝ For the second scenario, I thought it should be till 15 mins for WHO and till 30 mins for FDA and EMA. This because the time point for the comparator at 15 mins was 88% while the time point for the test product at 30 mins was 89%. These were the points when >85% was first achieved. Please confirm if I'm right.

1 time point have to be added in the calculation of f2 after reaching the 85% releasing time point, i.e
WHO: 20 min
EMA & FDA: 45

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% release wienui 2018-04-25 18:46
        
        Sample after >85% release Obinoscopy 2018-04-27 02:51
        
        Sample after >85% releasewienui 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