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 Obinoscopy – USA, 2020-07-16 16:36 (1817 d 21:23 ago) – Posting: # 21715
Views: 5,469

❝ … 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.

—
Scopy

Complete thread:

Biowaiver for lower strength using different OGD media dshah 2020-07-13 08:09
- 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 drugsObinoscopy 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 Biowaiver wienui 2020-07-18 18:00