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

posted by Relaxation  – Germany, 2020-07-16 10:54 (223 d 18:07 ago) – Posting: # 21707
Views: 976

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.

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