Bioequivalence and Bioavailability Forum

Dear, according recommendations from FDA: "Rivaroxaban demonstrated a steep exposure-response relationship for both efficacy and safety; therefore applicants should not use the reference-scaled average bioequivalence (BE) approach to widen the BE limits for rivaroxaban BE evaluation. Applicants should use the average BE approach with BE limits of 80-125%. The within-subject variability of test (T) and reference (R) products should be compared, and the upper limit of the 90% confidence interval for the test-to-reference ratio of the within-subject variability should be ≤ 2.5".

Guidance: UCM461150

On the other hand, EMA suggests "two single dose studies, since there is a different food effect resulting in different food recommendations. One study under fasting conditions with the 10 mg strength and one study under fed conditions with the 20 mg strength".

Scientific_guideline_WC500195126.

Is there right or wrong in this case? Or are there two different criterias to prove the same?