Bioequivalence and Bioavailability Forum • Biowaiver only for BCS I and – under certain conditions

Biowaiver only for BCS I and – under certain conditions – BCS III drugs [Dissolution / BCS / IVIVC]

posted by dshah – India, 2020-07-17 08:27 (1548 d 22:26 ago) – Posting: # 21728
Views: 4,040

❝ ❝ … is the end of the story.

❝

❝ He is seeking additional strength biowaiver and not BCS based biowaiver. The story might not have ended after all....there should be a sequel somewhere.

Thank you everyone for your valuable suggestions!

Yes, I am seeking for additional strength biowaiver through in vitro dissolution testing.
Is there any alternative for media selection?
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?

Regards,
dshah

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 drugsdshah 2020-07-17 06:27
        
        Additional Strength Biowaiver Requirements Obinoscopy 2020-07-18 03:13
        Additional strength Biowaiver wienui 2020-07-18 18:00