Power in the pivotal study (EU) [Power / Sample Size]

posted by valivetiananth – India, 2018-05-31 13:49  – Posting: # 18832
Views: 3,650

Dear All,

Greetings!!!

We have conducted a pivotal study for Europe with 48 subjects considering ~80% power, ISCV: 23%. The study was bioequivalent and 90% CI is within 80-125 for both Cmax & AUCt.

Power of Cmax and AUCt are 92% & 66% respectively. Kindly guide us how to justify the power less than 80% to HA.


Thanks
Valiveti

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