NTI drug but with high CV [Power / Sample Size]

posted by Mikalai  – Belarus, 2019-12-14 15:39 (353 d 07:09 ago) – Posting: # 20975
Views: 1,635

Dear all.
What would be a sample size for a BE study when the CV of the drug is 30% but bioequivalence should be in range 90_110%? Our assumption is around 400 subject if the design is standard, and 200 if the design is replicative
Best regards.

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