Bioequivalence and Bioavailability Forum

Statistically different or clinically different [General Statistics]

posted by ElMaestro – Denmark, 2014-03-14 08:10 (4487 d 13:25 ago) – Posting: # 12619
Views: 10,918

Hi Kumarnaidu,

❝ 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.

You have shown BE by ordinary standards. Just submit the dossier. DK can only theoretically kill it if they are the RMS in a DCP/MRP. But I doubt they will try.

—
Pass or fail!
ElMaestro

Complete thread:

Treat significance shri 2008-09-05 07:42 [General Statistics]
- 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 different kumarnaidu 2014-03-14 06:54
        
        Statistically different or clinically differentElMaestro 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]