Bioequivalence and Bioavailability Forum

This monkey business [Power / Sample Size]

posted by jag009  – NJ, 2013-06-14 01:06 (4763 d 16:10 ago) – Posting: # 10786
Views: 14,407

Hi Helmut!

❝ 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.

16 to finish I assume?

❝ ❝ 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've been dealing with too many nasty drugs...

❝ ❝ 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 form his vacation.

Will do

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 business jag009 2013-06-13 21:42
              • This monkey business Helmut 2013-06-13 22:12
                • This monkey businessjag009 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