Rivaroxaban: FDA and others [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2022-07-04 15:19 (206 d 15:00 ago) – Posting: # 23104
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Hi Tricky,

❝ Is it possible to go with Single-dose, two-treatment, two-sequence, two-period crossover study design?


It depends on the ‘target’ agency. For the FDA and China’s CDE no way because you have to compare the within-subject variability of test and reference. That requires a full replicate design. For details see the warfarin-guidance (ignore the part about reference-scaling; for rivaroxaban the conventional limits of 80.00–125.00% are applicable).

For all other agencies a 2×2×2 likely would do. In the EMA’s product-specific guidance no design is mentioned. However, riva­roxaban may show high variability, esp. in fed state. Be prepared for large sample sizes.

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