Bioequivalence and Bioavailability Forum • Alpha inflation in two stage design

Alpha inflation in two stage design [Two-Stage / GS Designs]

posted by kumarnaidu – Mumbai, India, 2013-12-04 14:43 (4219 d 05:49 ago) – Posting: # 11999
Views: 25,531

Hi all,
In one of BEBAC presentation Page 45 http://bebac.at/lectures/Prague2012-2.pdf
a below statement is written.
Deficiency 2: The Applicant should demonstrate that the
type I error inflation which can be expected from the
chosen approach, did not impact on the decision of
bioequivalence.

Response 2: One million simulations based on study’s
sample size and CV.
α_emp 0.0494 (95% CI: 0.0490 – 0.049)

Here I want to ask if I want to demonstrate that type error inflation did not impact on my study then can I demonstrate this by simply showing 90% CI as well as 94.12% CI for GMR of PK parameters within the acceptance limits (80% to 125%).
also I am not getting how to interpret Response 2

—
Kumar Naidu

Complete thread:

Acceptance by FDA/CDER Mahesh 2013-08-06 06:12
- Two stage BE design ElMaestro 2013-08-06 10:05
- Two stage BE design Helmut 2013-08-06 15:31
  - Two stage BE design Mahesh 2013-08-07 06:51
    - Two stage BE design kumarnaidu 2013-10-17 15:08
      - Two stage BE design ElMaestro 2013-10-17 17:28
        
        Two stage BE design kumarnaidu 2013-10-18 05:59
        
        EMA vs. rest of the world Helmut 2013-10-18 14:42
        
        Two stage BE design — cold water thrown on our head Shuanghe 2013-10-18 10:05
        
        Open your mouth and forcefully spit the water out Helmut 2013-10-18 13:29
        
        Change in statistical design kumarnaidu 2013-10-19 07:52
        
        Bad idea Helmut 2013-10-19 15:04
        
        Bad idea kumarnaidu 2013-10-21 06:01
        
        Change to Method B? Helmut 2013-10-21 14:51
        
        Change to Method B? kumarnaidu 2013-10-22 06:15
        
        Simulations Helmut 2013-10-22 13:20
        
        Open your mouth and forcefully spit the water out Shuanghe 2013-10-22 09:03
        
        Reach for the stars Helmut 2013-10-22 13:05
        
        Alpha inflation in two stage designkumarnaidu 2013-12-04 13:43
        
        Deficiency letters Helmut 2013-12-04 14:50
        
        Deficiency letters kumarnaidu 2013-12-05 06:18
        
        Simulations Helmut 2013-12-05 15:51
        
        Simulations kumarnaidu 2013-12-05 16:07
        
        Simulations Helmut 2013-12-05 16:55
        
        Simulations kumarnaidu 2013-12-06 06:07
        
        Ejaculatio praecox Helmut 2013-12-06 14:30
        
        Ejaculatio praecox kumarnaidu 2013-12-06 15:13
        
        All effects fixed Helmut 2013-12-06 15:31
        
        All effects fixed kumarnaidu 2013-12-09 07:33
        
        EMA… Helmut 2013-12-09 12:45