Bioequivalence and Bioavailability Forum • This monkey business

This monkey business [Power / Sample Size]

posted by ElMaestro – Denmark, 2013-06-14 03:57 (4751 d 13:21 ago) – Posting: # 10787
Views: 14,228

Hi John,

❝ ❝ Hhm, why don’t you save the money (or wire somefink to my bank account instead) and submit the pilot study as pivotal evidence of BE?

❝

❝ Good question. I asked the Senior mgt too and they said it's a pilot batch but manufactured with pivotal specification. I don't understand their answer. I will go digging and see if they know what they are talking about.

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.

—
Pass or fail!
ElMaestro

Complete thread:

This power business jag009 2013-06-13 16:49
- 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 businessElMaestro 2013-06-14 01:57
      - This monkey business jag009 2013-06-14 20:49