Bioequivalence and Bioavailability Forum • This monkey business

This monkey business [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2013-06-13 23:33 (4762 d 13:03 ago) – Posting: # 10783
Views: 14,371

Hi John!

❝ […] Okay, it's from the 2001 guidance and RSABE was introduced much later...

I think that’s the crucial point. At a Pharmaceutical Science Advisory Committee Meeting FDA suggested a minimum of 36 subjects and was voted down (have to dig out the reference). From what I’ve heard at conferences they want 24 – but I was never able to find a reference.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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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 businessHelmut 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 business jag009 2013-06-14 20:49