Bioequivalence and Bioavailability Forum

This monkey business [Power / Sample Size]

posted by jag009  – NJ, 2013-06-13 23:42 (4753 d 09:04 ago) – Posting: # 10784
Views: 14,256

❝ ❝ […] 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.

You mean this? Link

Given the fact that the CV>30%, do you think that it's possible for anyone(I mean would anyone dare to)try and pass a RSABE study with n=12? It's risky enough to run a regular submission BE study with n=12 already at CV<30%... I will go check with my professor and see (Dr.Endrenyi) when I go have dinner with him later...

John

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 businessjag009 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