Bioequivalence and Bioavailability Forum • F1 and F2 values and dissolution profile

F1 and F2 values and dissolution profile [Dissolution / BCS / IVIVC]

posted by Aceto81 – Belgium, 2009-03-05 13:30 (5912 d 01:22 ago) – Posting: # 3320
Views: 27,414

Hi,

if you want to use F1 and F2 values for you comparison of your generic formulation with a reference formulation, you may only have 1 point after 85%, so you need 3 - 4 points before 85% release.
Also you need to test 12 samples.
If your component is rapid dissolving (> 85% in <=15min), you don't have to perform F1 and F2 comparison.
Besides this: F2 should be between 50 - 100, so based on your calculations: equivalence isn't shown.

For a reference about dissolution comparison: http://www.dissolutiontech.com/DTresour/899Art/DissProfile.html

Kind regards

Ace

Complete thread:

F1 and F2 values and dissolution profile govardhanpillari 2009-03-04 12:30 [Dissolution / BCS / IVIVC]
- F1 and F2 values and dissolution profile drcampos 2009-03-04 13:51
- F1 and F2 values and dissolution profileAceto81 2009-03-05 12:30
  - F1 and F2 values and dissolution profile Helmut 2009-03-05 14:01
  - F1 and F2 values and dissolution profile govardhanpillari 2009-03-06 06:04
    - F1 and F2 values and dissolution profile drcampos 2009-03-06 14:31
      - F1 and F2 values and dissolution profile govardhanpillari 2009-03-07 05:47
- US RLD / European reference Helmut 2009-03-05 14:15
  - European reference Ohlbe 2009-03-05 19:09
- F1 and F2 values and dissolution profile jayeshd 2010-04-17 08:58
  - EU + US Ohlbe 2010-04-17 20:19
  - F1 and F2 values and dissolution profile Dr_Dan 2010-04-19 14:51