Bioequivalence and Bioavailability Forum

Statistically different or clinically different [General Statistics]

posted by kumarnaidu – Mumbai, India, 2014-03-14 07:54 (4487 d 15:01 ago) – Posting: # 12618
Views: 10,971

Hi all,
I have one study result with me of diuretic class drug. The study was refrence replicated study with N=50. The result obtained is given below
Cmax - 91.41(83.04 - 100.62), CV=34.25, Power=96.82
AUC(0 to t)- 90.14(85.78 - 94.72) , CV=17.31, Power=100.00

As we understand, in Nordic countries, it is a requirement that the interval cover 100% in order to obtain generic substitution. In view of this requirement and our study results what should be the possible justification we can present to the agency if query come.

—
Kumar Naidu

Complete thread:

Treat significance shri 2008-09-05 07:42
- Treat significance ElMaestro 2008-09-05 08:50
  - Denmark Ohlbe 2008-09-05 10:27
    - Denmark ElMaestro 2008-09-05 12:02
      - Denmark Ohlbe 2008-09-05 12:31
        
        Denmark ElMaestro 2008-09-05 13:03
    - Denmark shri 2008-09-06 10:25
      - Statistically different or clinically different Ohlbe 2008-09-06 16:43
        
        Statistically different or clinically different shri 2008-09-08 06:29
        
        Statistically different or clinically differentkumarnaidu 2014-03-14 06:54
        
        Statistically different or clinically different ElMaestro 2014-03-14 07:10
        
        Statistically different or clinically different kumarnaidu 2014-03-14 12:36
        
        Post hoc power #666 Helmut 2014-03-14 13:31
        Post hoc power - power of which test? d_labes 2014-03-14 13:53
        
        Post hoc power - power of which test? kumarnaidu 2014-03-15 10:56

Statistically different or clinically different [General Sta­tis­tics]

Complete thread:

Statistically different or clinically different [General Statistics]