156 ? [Study As­sess­ment]

posted by d_labes  – Berlin, Germany, 2014-07-08 12:03 (3003 d 19:47 ago) – Posting: # 13238
Views: 11,073

Dear unique_one.

» Could you please let me know that what could be in approx sample size if study is repeated?

Simple enough using PowerTOST:
Approach: The Believer’s ("Carved in stone")
AUC
sampleN.TOST(CV=0.273, theta0=1.122, print=F)
  Design alpha    CV theta0 theta1 theta2 Sample size Achieved power Target power
1    2x2  0.05 0.273  1.122    0.8   1.25          78       0.802053          0.8
Cmax
sampleN.TOST(CV=0.282, theta0=1.095, print=F)
  Design alpha    CV theta0 theta1 theta2 Sample size Achieved power Target power
1    2x2  0.05 0.282  1.095    0.8   1.25          56      0.8039018          0.8


Approach: The Conservative’s
AUC
sampleN.TOST(CV=0.3, theta0=1.15, print=F)
  Design alpha  CV theta0 theta1 theta2 Sample size Achieved power Target power
1    2x2  0.05 0.3   1.15    0.8   1.25         156      0.8030697          0.8
Cmax
sampleN.TOST(CV=0.3, theta0=1.1, print=F)
  Design alpha  CV theta0 theta1 theta2 Sample size Achieved power Target power
1    2x2  0.05 0.3    1.1    0.8   1.25          68      0.8073325          0.8


Thus a relative conservative estimate (more conservative assumptions about CV and GMR are imaginable) of sample size would be 156. Seldom seen such a high sample size in BE studies.

Regards,

Detlew

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