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RegisterBE study Design for Rivaroxaban 20 mg [Design Issues]
Hello!
The Design for Rivaroxaban 20 mg BE Study stated by US-FDA is as follows:
Single-dose, two-treatment, two-sequence, four-period, fully replicate crossover
Is it possible to go with Single-dose, two-treatment, two-sequence, two-period crossover study design?
Thank You!
Edit: Category changed; see also this post #1. Guidance linked. [Helmut]
The Design for Rivaroxaban 20 mg BE Study stated by US-FDA is as follows:
Single-dose, two-treatment, two-sequence, four-period, fully replicate crossover
Is it possible to go with Single-dose, two-treatment, two-sequence, two-period crossover study design?
Thank You!
Edit: Category changed; see also this post #1. Guidance linked. [Helmut]
Complete thread:
- BE study Design for Rivaroxaban 20 mgTricky TAB 2022-07-04 11:33
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Rivaroxaban: FDA and others Helmut 2022-07-04 13:19
- Rivaroxaban: FDA and others Tricky 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
- Rivaroxaban: FDA and others Helmut 2022-07-05 09:49
- Rivaroxaban: FDA and others Tricky TAB 2022-07-05 06:42
- Rivaroxaban: FDA and others Helmut 2022-07-04 13:19
Ing. Helmut Schütz