Rivaroxaban: FDA and others [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2022-07-05 11:49 (739 d 15:14 ago) – Posting: # 23106
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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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