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

posted by Relaxation  – Germany, 2020-07-16 12:54 (1813 d 08:33 ago) – Posting: # 21707
Views: 5,494

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:

UA Flag
Activity
 Admin contact
23,426 posts in 4,929 threads, 1,682 registered users;
40 visitors (0 registered, 40 guests [including 23 identified bots]).
Forum time: 21:28 CEST (Europe/Vienna)

You can do one of two things; just shut up,
which is something I don’t find easy,
or learn an awful lot very fast,
which is what I tried to do.    Jane Fonda

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5