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Dear Sir,
Actually it is a parallel study.
maximum Pooled CV=53.0%
Therefore, if we take actual maximum difference 116.66%.
then 1286 completed subjects will be appropriate sample size to get 90% confidence interval of Log Transformed Cmax, AUC0-t and AUC0-inf data within 80 - 125 % to achieve 80% power at 5% level of significance.
Is sample size based on actual maximum T/R ratio difference?
Sir, I need your guidence.
Actually it is a parallel study.
maximum Pooled CV=53.0%
Therefore, if we take actual maximum difference 116.66%.
then 1286 completed subjects will be appropriate sample size to get 90% confidence interval of Log Transformed Cmax, AUC0-t and AUC0-inf data within 80 - 125 % to achieve 80% power at 5% level of significance.
Is sample size based on actual maximum T/R ratio difference?
Sir, I need your guidence.
—
Best Regards,
Yuvraj
Best Regards,
Yuvraj
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