Bioequivalence and Bioavailability Forum • EMA: No biowaivers for NTIDs

EMA: No biowaivers for NTIDs [Dissolution / BCS / IVIVC]

posted by Relaxation – Germany, 2020-07-16 10:54 (195 d 04:58 ago) – Posting: # 21707
Views: 916

Hello everyone.

Just to complement the answer quickly.
There actually is a product-specific guidance for rivaroxaban. I hope that I do not mix something up, but it currently seems valid.
Its just not considering it as an NTI as the recommended acceptance range is not narrowed in accordance with the basic BE-Guideline.

https://www.ema.europa.eu/en/rivaroxaban-product-specific-bioequivalence-guidance

Note: other authorities see this differently.

Best regards,
Steven.

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 NTIDsRelaxation 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 Biowaiver wienui 2020-07-18 18:00