Bioequivalence and Bioavailability Forum • PowerTOST sample size FDA full replicate T/R ratio at 85%

PowerTOST sample size FDA full replicate T/R ratio at 85% [🇷 for BE/BA]

posted by Shuanghe – Spain, 2016-01-26 13:55 (3377 d 05:11 ago) – Posting: # 15854
Views: 17,867

Many thanks Detlew!

❝ "Not widened yet" is the false. ...

❝

❝ So far so good. This doesn't imply that at CV=30% the sample size is highest since we have the point estimate constraint in effect. This leads to the shift of the maximum sample size downwards of 30%.

Understood until here.

❝ This is also the case for your calculations with theta0=0.9, but not so pronounced seen as with theta0=0.85. Check it by power calculations with n=120 for theta0=0.85 or theta0=0.9 and n=32. You will find the minimum (implying max. sample size) below CV=30% in both cases.

Confused by this part. :confused:

❝ The why is not so easy to answer. ... My suggestion: Take the observed effect as is :cool: .

I think I'll just take what it is as you said. Much easier this way :-D

❝ Of course not! Even the suspicion is an injury :-D !

❝ It must be correct because PowerTOST says so :cool: .

—
All the best,
Shuanghe

Complete thread:

PowerTOST sample size FDA full replicate T/R ratio at 85% Shuanghe 2016-01-25 17:49
- PowerTOST sample size FDA full replicate T/R ratio at 85% d_labes 2016-01-26 12:05
  - PowerTOST sample size FDA full replicate T/R ratio at 85%Shuanghe 2016-01-26 12:55
    - PowerTOST sample size FDA full replicate T/R ratio at 85% d_labes 2016-01-26 14:07
    - maximum sample size at which CV? Helmut 2016-01-26 16:31
      - maximum sample size at which CV? nobody 2016-01-26 17:40
      - maximum sample size at which CV? d_labes 2016-01-27 08:41
        
        maximum sample size at which CV? nobody 2016-01-27 09:08
        
        OT: Stop - think -act d_labes 2016-01-27 09:31
      - maximum sample size at which CV? Shuanghe 2016-01-28 12:44
        
        target power 90% Helmut 2016-01-28 13:49
        
        PowerTOST update d_labes 2016-02-01 19:16
        
        #1,000 Helmut 2016-02-01 21:49
        
        OT: post #1,000 d_labes 2016-02-02 21:17
        #1,000 ElMaestro 2016-02-03 16:32
        
        #1,000 Helmut 2016-02-03 16:50
        OT: #1,000 d_labes 2016-02-05 15:50
        
        OT: #1,000 ElMaestro 2016-02-05 17:02
        
        OT: #1,000 d_labes 2016-02-05 19:48
        
        OT: #1,000 ElMaestro 2016-02-06 15:45
        
        OT: #1,000 nobody 2016-02-07 09:50