Bioequivalence and Bioavailability Forum • TIE: questions

TIE: questions [RSABE / ABEL]

posted by mittyri – Russia, 2015-02-03 13:44 (3753 d 10:34 ago) – Posting: # 14361
Views: 22,790

Dear Helmut,

Could you please help with the following questions:

1. Could you explain:

❝ At 30% the chance for such a wrong decision is 50%. Therefore, we can expect the highest inflation of the TIE at 30%.

But:

❝ Maximum inflation of the TIE 0.0684 (at CV 30.1%).

(in your post below)

Why the maximum inflation is not observed exactly at 30%?

2. Where did you get the image with inflation of the TIE? (is it possible to find it in high resolution?)
As I understand the TIE in this image can be changed to CI for adjusted α. (So the black line is the line of 90% CI)

3. I read this thread one more time, but didn't catch one thing
For example before the study (TRT|RTR) I have estimated number of subjects 42 proceeded from expected CV (40%), required power (80%), TIE (5%) and expected Ratio (90% for HVD).
OK, I'm on a lucky side, the CV and GMR were as expected.
After that I should adjust the TIE (and wide the CI). And new CI could be outside the limits!
Could I expect it and plan the study in accordance with coming procedure of TIE adjusting?
Yes, it is not possible to counteract the inflation by a prespecified adjusted α, but as well as for power is it possible to use some "critical limits"?

—
Kind regards,
Mittyri

Complete thread:

EMA oracle Helmut 2015-01-27 16:27 [RSABE / ABEL]
- EMA oracle nobody 2015-01-27 17:07
- Personal opinion ElMaestro 2015-01-27 17:56
- EMA oracle d_labes 2015-01-27 19:44
  - EMA oracle nobody 2015-01-28 09:04
    - EMA oracle ElMaestro 2015-01-28 13:11
- Response from Alfredo García-Arieta Helmut 2015-01-30 10:55
  - Response from Alfredo García-Arieta nobody 2015-01-30 14:55
    - Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 01:35
      - Wonnemann’s Figure 4 on steroids nobody 2015-02-01 11:18
        
        Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 14:49
      - General remarks ElMaestro 2015-02-01 18:43
        
        General remarks nobody 2015-02-01 22:04
        General remarks Helmut 2015-02-02 00:48
        
        General remarks nobody 2015-02-02 08:09
        
        General remarks Helmut 2015-02-02 14:06
        
        TIE: questionsmittyri 2015-02-03 12:44
        
        TIE: questions Helmut 2015-02-03 13:24
        
        FDA RSABE & alpha inflation d_labes 2015-02-03 12:02
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 12:22
        
        FDA RSABE & alpha inflation d_labes 2015-02-03 13:07
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 13:41
- New Zealand nobody 2015-01-31 11:25
  - New Zealand Helmut 2015-02-01 16:08
    - New Zealand nobody 2015-02-01 22:08
      - New Zealand Helmut 2015-02-01 23:54
        
        New Zealand nobody 2015-02-02 08:07