Bioequivalence and Bioavailability Forum • f2 Calculation For Rapidly Dissolving FPPs

f2 Calculation For Rapidly Dissolving FPPs [Dissolution / BCS / IVIVC]

posted by Obinoscopy – USA, 2018-04-22 15:11 (1579 d 07:07 ago) – Posting: # 18718
Views: 11,068

Dear All,

Even though I have not come across this scenario in practice, I am imagining a situation where a test product is rapidly dissolving (>85% in 30 mins) while the comparator product is very rapidly dissolving (>85% in 15 mins) and vice versa. Is f2 calculation necessary? If it is, which time points will be used?

I am aware, the requirements are different for different NRAs (USFDA, EMEA, WHO, etc). I will appreciate if these are taken into account when answering this question.

Regards,

—
Scopy

Complete thread:

f2 Calculation For Rapidly Dissolving FPPsObinoscopy 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% 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