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RegisterNTI drug but with high CV [Power / Sample Size]
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.
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.
Complete thread:
- NTI drug but with high CVMikalai 2019-12-14 15:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- NTI drug with high CV? Helmut 2019-12-14 16:11
Ing. Helmut Schütz