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 (2166 d 06:47 ago) – Posting: # 21710
Views: 7,495

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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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 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

Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
145 visitors (0 registered, 145 guests [including 27 identified bots]).
Forum time: 20:14 CEST (Europe/Vienna)

Science is simply common sense at its best that is,
rigidly accurate in observation, and
merciless to fallacy in logic. Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz