HC: Sample size for AUC and Cmax: exact and sim’s [Power / Sample Size]

posted by VStus – Poland, 2017-01-31 14:44 (2613 d 22:27 ago) – Posting: # 17001
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Dear zizou,
Dear Helmut,

Thank you very much! At first I though that RStudio got frozen :)

Sorry for not responding earlier, notification has not worked.

In the meantime, Canadian CRO just used Intra-subject variability of AUCt (very low) with extreme T/R to justify the sample size of 24. And we have reasons to assume that real T/R for Cmax is far below unity. This gives less than 60% power on 24 subjects, but still more than just a coin flip :-D And almost no one will want to run bioequivalence study on hundreds of subjects...

Regards, VStus

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