Some philosophy [Power / Sample Size]

posted by BE-proff – 2015-12-26 17:44 (3478 d 17:27 ago) – Posting: # 15767
Views: 5,790

Hi All,

If to conduct a BE-study with alfa error 5% and power 80% it means that a customer has 5% risk to buy non-BE medication and a developer has 20% risk to reject bioequivalent drug.

So, if we failed BE-study because PK-parameters were out of acceptance range may be we were "unlucky" and fall into 20% risk? :confused:

I wonder if there are any ways to decrease risk except sample sizing? :confused:

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