Power to the people [Two-Stage / GS Designs]

posted by d_labes  – Berlin, Germany, 2015-10-07 15:49 (3447 d 16:48 ago) – Posting: # 15525
Views: 11,156

Hi John John

Cmax   CVintrasub (0.387)  Ratio(%Ref) (81.439)

❝                BEQ (70.162-94.529)
❝               Power at 20% (0.715)


❝ AUC0-t CVintrasub (0.324)  Ratio(%Ref) (110.662)

❝               BEQ (97.552-125.534)
❝              Power at 20% (0.846)


Whatever your power values stand for, they are not the correct ones for the Potvin TSD, method B.
You have to calculate the power at GMR=0.95, with alpha=0.0294 and CV from stage 1.

Here my results:
# Cmax
power.TOST(alpha=0.0294, CV=0.387, n=36, theta0=0.95)
[1] 0.3783821
# AUC
power.TOST(alpha=0.0294, CV=0.324, n=36, theta0=0.95)
[1] 0.5946074


Both are below the targeted 80%. Thus your problem described above doesn't exists.

Regards,

Detlew

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