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RegisterRivaroxaban: FDA and others [Design Issues]
posted by Helmut 
– Vienna, Austria, 2022-07-05 11:49 (511 d 22:22 ago) – Posting: # 23106
Views: 1,503
Hi Tricky,
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.
❝ 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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Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- BE study Design for Rivaroxaban 20 mg Tricky TAB 2022-07-04 11:33 [Design Issues]
![[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 othersHelmut 2022-07-05 09:49
- Rivaroxaban: FDA and others Tricky TAB 2022-07-06 06:52
- Rivaroxaban: FDA and othersHelmut 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