Bioequivalence and Bioavailability Forum • This monkey business

This monkey business [Power / Sample Size]

posted by jag009 – NJ, 2013-06-14 22:49 (4350 d 00:29 ago) – Posting: # 10799
Views: 10,390

Hi ElMaestro,

❝ Sounds to me like the batch size was insufficient for a pivotal trial. Then the production will be upscaled and a pivotal trial run 'soon' with the usual risk of funny outcomes. T/R can be a joker in these cases.

No no. Batch size is sufficient. Something to do with methods being not validated with the "pilot" Batch. I just don't feel well with such a large CV that's all.

John

Complete thread:

This power business jag009 2013-06-13 16:49 [Power / Sample Size]
- This monkey business Helmut 2013-06-13 17:40
  - This monkey business jag009 2013-06-13 19:57
    - This monkey business Helmut 2013-06-13 20:04
      - This monkey business jag009 2013-06-13 21:24
        
        This monkey business Helmut 2013-06-13 21:33
        
        This monkey business jag009 2013-06-13 21:42
        
        This monkey business Helmut 2013-06-13 22:12
        
        This monkey business jag009 2013-06-13 23:06
        
        Minimum sample size for RSABE = 24 (enrolled) Helmut 2013-06-14 15:43
        
        Minimum sample size for RSABE = 24 (enrolled) jag009 2013-06-14 22:06
    - This monkey business ElMaestro 2013-06-14 01:57
      - This monkey businessjag009 2013-06-14 20:49