156 ? [Study As­sess­ment]

posted by d_labes  – Berlin, Germany, 2014-07-08 14:03 (3573 d 21:07 ago) – Posting: # 13238
Views: 12,048

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

Complete thread:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,658 registered users;
111 visitors (0 registered, 111 guests [including 5 identified bots]).
Forum time: 11:10 CEST (Europe/Vienna)

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5