Bioequivalence and Bioavailability Forum • Additional strength Biowaiver

Additional strength Biowaiver [Dissolution / BCS / IVIVC]

posted by wienui – Germany/Oman, 2020-07-18 18:00 (713 d 07:14 ago) – Posting: # 21742
Views: 2,002

Dear dshah & All,

» I believe 2.5X8 tab Vs 20 mg, 10X2 tab vs 20 mg and 15 vs 20 mg strength using 0.4% SDS media is one of the option, but is there any other options for dissolution comparision?

Yes, I think your suggestion for the in vitro comparative dissolution testing for the other additional strength biowaivers is correct. ( take care of the sink conditions).

Beside the dissolution, the followings have to be fulfilled (EMA):

- Amount of API must be < 5% of tablet core weight in the BE strength and the biowaiver strength, and
- Amounts of excipients are same per strength, or
- Only the amount of a filler is changed to account for changes in API weight.

—
Cheers,
Osama

Complete thread:

Biowaiver for lower strength using different OGD media dshah 2020-07-13 08:09 [Dissolution / BCS / IVIVC]
- EMA: No biowaivers for NTIDs Helmut 2020-07-15 19:08
  - EMA: No biowaivers for NTIDs Relaxation 2020-07-16 10:54
    - Biowaiver only for BCS I and – under certain conditions – BCS III drugs Helmut 2020-07-16 11:27
      - Biowaiver only for BCS I and – under certain conditions – BCS III drugs Obinoscopy 2020-07-16 14:36
        
        Biowaiver only for BCS I and – under certain conditions – BCS III drugs dshah 2020-07-17 06:27
        
        Additional Strength Biowaiver Requirements Obinoscopy 2020-07-18 03:13
        Additional strength Biowaiverwienui 2020-07-18 18:00