Bioequivalence and Bioavailability Forum • sample size for BA/BE studies

sample size for BA/BE studies [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2008-11-17 15:32 (6058 d 07:18 ago) – Posting: # 2694
Views: 8,006

Hehe,
Dear dr. muneesh,
I think your situation is sort of potentially borderline nasty.
If the true T/R (CV) is close to the value you have observed then 'there might be an issue'.
Could I ask, how do your formulations perform comparatively in the dissolution assay (for the batches you have evaluated in the human pilot study) ???

Best regards
EM.

Complete thread:

sample size for BA/BE studies drmuneesh 2008-10-18 09:17 [Regulatives / Guidelines]
- sample size for BA/BE studies shankar 2008-10-18 11:47
  - sample size for BA/BE studies drmuneesh 2008-10-18 12:18
    - sample size for BA/BE studies Ohlbe 2008-10-18 13:32
      - sample size for BA/BE studies drmuneesh 2008-10-19 10:42
      - sample size for BA/BE studies drmuneesh 2008-11-17 14:10
        
        sample size for BA/BE studiesElMaestro 2008-11-17 14:32
        
        sample size for BA/BE studies drmuneesh 2008-11-18 10:34
        sample size for BA/BE studies drmuneesh 2008-11-28 07:50
        
        sample size for BA/BE studies Helmut 2008-11-17 15:47
        
        sample size for BA/BE studies drmuneesh 2008-11-18 07:44
        
        sample size for BA/BE studies ElMaestro 2008-11-18 08:49
        
        sample size for BA/BE studies drmuneesh 2008-11-18 09:31
        
        sample size for BA/BE studies ElMaestro 2008-11-18 09:59
        
        sample size for BA/BE studies drmuneesh 2008-11-18 10:27
        
        sample size for BA/BE studies drmuneesh 2008-11-19 10:14
        
        sample size for BA/BE studies ElMaestro 2008-11-19 10:48
        
        sample size for BA/BE studies drmuneesh 2008-11-20 08:30
        
        CVintra # CVinter # CVtotal Helmut 2008-11-20 11:18
        
        Circulus vitiosus d_labes 2008-11-20 13:57
        
        Sterne! Helmut 2008-11-20 18:11
        
        CVintra # CVinter # CVtotal drmuneesh 2008-11-28 10:37
        
        CVintra # CVinter # CVtotal Helmut 2008-11-29 10:14
        
        CVintra # CVinter # CVtotal drmuneesh 2008-11-30 07:18
        
        is something fishy in case 2? ElMaestro 2008-11-29 15:42
        
        is something fishy in case 2? drmuneesh 2008-11-30 07:17
        
        SAS and sample size d_labes 2008-11-19 11:33
        
        SAS and sample size drmuneesh 2008-11-20 08:31