Rivaroxaban: FDA and others [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2022-07-04 15:19 (713 d 14:51 ago) – Posting: # 23104
Views: 2,079

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
154 visitors (0 registered, 154 guests [including 74 identified bots]).
Forum time: 06:10 CEST (Europe/Vienna)

If you tell the truth you don’t have to remember anything.    Mark Twain

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