Bioequivalence and Bioavailability Forum • Deficiency letters

Deficiency letters [Two-Stage / GS Designs]

posted by kumarnaidu – Mumbai, India, 2013-12-05 07:18 (4218 d 23:30 ago) – Posting: # 12005
Views: 25,637
(edited on 2013-12-05 12:19)

Hi Helmut,
In my study CV is around 19% and sample size was 28 so can I use CV=20% and sample size stage 1(n1)=24 here as 28 is not there in the table.

1. By using CV=20% and n=24

        Exact binomial test



data:  alpha * sims and sims

number of successes = 49000, number of trials = 1e+06, p-value <

2.2e-16

alternative hypothesis: true probability of success is not equal to 0.5

95 percent confidence interval:

 0.04857771 0.04942490

sample estimates:

probability of success

                 0.049

2. By using CV=20% and n=36

      Exact binomial test



data:  alpha * sims and sims

number of successes = 49900, number of trials = 1e+06, p-value <

2.2e-16

alternative hypothesis: true probability of success is not equal to 0.5

95 percent confidence interval:

 0.04947404 0.05032856

sample estimates:

probability of success

                0.0499

In second case upper limit of type 1 error rate is 0.05032 (exceeding 0.05),Is it means that here type 1 error inflation is present and regulator may reject the application.

—
Kumar Naidu

Complete thread:

Acceptance by FDA/CDER Mahesh 2013-08-06 06:12 [Two-Stage / GS Designs]
- 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 design kumarnaidu 2013-12-04 13:43
        
        Deficiency letters Helmut 2013-12-04 14:50
        
        Deficiency letterskumarnaidu 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