Bioequivalence and Bioavailability Forum • Using f2 for compounds that never reach 85% dissolution

Using f2 for compounds that never reach 85% dissolution [Dissolution / BCS / IVIVC]

posted by Dr_Dan – Germany, 2017-01-16 19:10 (3092 d 13:49 ago) – Posting: # 16959
Views: 6,516

Dear wligtenberg
I am not experienced in this field, but if I look at EMA/CHMP/806058/2009/Rev. 02 see and take this analogously for products for ocular use I would ask you if it is really necessary to calculate f2 values in order to demonstrate similarity between the test liposomal product and the reference? Wouldn’t it be sufficient just to show the figures? According to this reflection paper IMHO you just need to address (among many others)

in vitro drug substance release rate from the liposome in physiologically/clinically relevant media. Reliable and discriminating validated in-vitro release methods should be developed to:
- monitor the simulated release of the active substance from the liposomes in physiologically/clinically relevant media. If justified an in vitro leakage test in relevant media under multiple conditions (e.g. range of temperatures and pH values) could be appropriate.

I hope this helps

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Using f2 for compounds that never reach 85% dissolution wligtenberg 2017-01-03 15:48 [Dissolution / BCS / IVIVC]
- Using f2 for compounds that never reach 85% dissolution nobody 2017-01-03 19:19
  - Using f2 for compounds that never reach 85% dissolution wligtenberg 2017-01-04 10:46
    - Using f2 for compounds that never reach 85% dissolution nobody 2017-01-04 11:52
- Using f2 for compounds that never reach 85% dissolution wligtenberg 2017-01-16 17:27
  - Using f2 for compounds that never reach 85% dissolutionDr_Dan 2017-01-16 18:10
    - Using f2 for compounds that never reach 85% dissolution wligtenberg 2017-01-17 09:00