Tricky TAB
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Bangladesh,
2022-07-04 13:33
(212 d 06:34 ago)

Posting: # 23103
Views: 1,046
 

 BE 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]
Helmut
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Vienna, Austria,
2022-07-04 15:19
(212 d 04:49 ago)

@ Tricky TAB
Posting: # 23104
Views: 799
 

 Rivaroxaban: FDA and others

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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Tricky TAB
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Bangladesh,
2022-07-05 08:42
(211 d 11:26 ago)

@ Helmut
Posting: # 23105
Views: 763
 

 Rivaroxaban: FDA and others

❝ 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]
Helmut
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Vienna, Austria,
2022-07-05 11:49
(211 d 08:19 ago)

@ Tricky TAB
Posting: # 23106
Views: 738
 

 Rivaroxaban: FDA and others

Hi Tricky,

❝ Wanted to perform BE for ASEAN Regions!

❝ 2x2x2 would matter anyway for those countries with same sample size as suggested in FDA guideline?


The FDA’s (and the EMA’s) guideline don’t give a sample size. Search the literature or – much better – perform a pilot study with your formulation.


PS: Did you also register with the user name ‘Tajbiul Alam’ (same IP like yours, registration seven minutes apart)? If yes, I will delete the other account.

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Bangladesh,
2022-07-06 08:52
(210 d 11:15 ago)

@ Helmut
Posting: # 23107
Views: 751
 

 Rivaroxaban: FDA and others


PS: Did you also register with the user name ‘Tajbiul Alam’ (same IP like yours, registration seven minutes apart)? If yes, I will delete the other account.


Yes Sir, Please delete the earlier one.


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! [Ohlbe]
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