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.


Note: other authorities see this differently.

Best regards,

Complete thread:

 Admin contact
21,316 posts in 4,446 threads, 1,489 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Wednesday 14:52 CET (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz