Rivaroxaban: FDA and others [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2022-07-05 09:49 (39 d 04:02 ago) – Posting: # 23106
Views: 328

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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