Bioequivalence and Bioavailability Forum • This monkey business

This monkey business [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2013-06-14 00:12 (4763 d 01:37 ago) – Posting: # 10785
Views: 14,356

Hi John!

❝ ❝ 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

Well, this gives a hint where to search.

At the April 14, 2004 meeting of the Advisory Committee of Pharmaceutical Science (ACPS), different approaches were discussed, […] Most members favored a minimum sample size of 24.

This was the one where FDA was voted down. I think nothing was mentioned at the October 6, 2006 meeting (though not sure). I’m not aware of any official statement about a minimum sample size.

❝ 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?

Well, if the study was planned for 80% power, CV <50%, and a GMR of 1 you would need 21. With a lot of drop-outs… In a full replicate (CV 30, GMR 1) you need only 16.

❝ It's risky enough to run a regular submission BE study with n=12 already...

Is it? With EMA I never had any problems.

❝ I will go check with my professor and see (Dr.Endrenyi) when I go have dinner with him later... :-)

Best regards! Tell him that we haven’t forgotten the α-inflation story (hint). Detlew just returned from his vacation.

—
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Helmut Schütz

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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 businessHelmut 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