different results from diff. software? [Power / Sample Size]

posted by ioanam – Romania, 2009-01-06 23:42 (6375 d 17:04 ago) – Posting: # 3001
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Good evening and Happy New Year,

I would like to receive an answer to my question.

After a pilot bioequivalence study, I obtained an intraCV for Cmax of 34%.

Sample size for the pivotal study obtained after statistical calculation was of 36 subjects.

The sponsor representative showed me other calculus for this parameter using different software, obtaining a number of 48 subjects.

Who is right in this case?

Thank you very much, Jo

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Edit: Subject line changed. [Helmut]

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