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

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

posted by Helmut – Vienna, Austria, 2020-07-16 13:27 (985 d 03:51 ago) – Posting: # 21710
Views: 2,524

Hi Steven,

THX! I was not aware of this one (should have searched my own guideline collection).

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

@dshah

BCS Classification BCS Class: ☐ I ☐ III ☒ Neither of the two
Background: rivaroxaban may be considered a low solubility compound.

… is the end of the story.

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Science Quotes

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 drugsHelmut 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

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