Bioequivalence and Bioavailability Forum • Power to the people

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

posted by d_labes – Berlin, Germany, 2015-10-07 15:49 (3123 d 03:17 ago) – Posting: # 15525
Views: 10,126

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

Complete thread:

Sequential trial with B method of Potvin john john 2015-10-01 17:44
- Sequential trial with B method of Potvin ElMaestro 2015-10-01 17:58
- Sequential trial with B method of Potvin Helmut 2015-10-01 18:13
  - Sequential trial with B method of Potvin john john 2015-10-07 11:26
    - Power to the peopled_labes 2015-10-07 13:49
      - Power to the people john john 2015-10-07 14:54
        
        Software? Ethics beyond statistics… Helmut 2015-10-07 16:06
        
        Subtraction of a df ElMaestro 2015-10-07 21:22
        
        df = df-1 d_labes 2015-10-08 08:10
    - Potvin B: α 0.0294 in both stages Helmut 2015-10-08 15:27
      - Potvin B: α 0.0294 in both stages john john 2015-10-23 12:04