Bioequivalence and Bioavailability Forum • Rivaroxaban: FDA and others

Rivaroxaban: FDA and others [Design Issues]

posted by Tricky TAB – Bangladesh, 2022-07-05 08:42 (145 d 02:44 ago) – Posting: # 23105
Views: 612

❝ It depends on the ‘target’ agency.

Thanks a lot, Helmut!
For taking the time to help me out!

Wanted to perform BE for ASEAN Regions!
2x2x2 would matter anyway for those countries with same sample size as suggested in FDA guideline?

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

Complete thread:

BE study Design for Rivaroxaban 20 mg Tricky TAB 2022-07-04 11:33 [Design Issues]
- Rivaroxaban: FDA and others Helmut 2022-07-04 13:19
  - Rivaroxaban: FDA and othersTricky TAB 2022-07-05 06:42
    - Rivaroxaban: FDA and others Helmut 2022-07-05 09:49
      - Rivaroxaban: FDA and others Tricky TAB 2022-07-06 06:52