Bioequivalence and Bioavailability Forum • Why not?

Why not? [Power / Sample Size]

posted by d_labes – Berlin, Germany, 2015-11-02 12:08 (3881 d 06:07 ago) – Posting: # 15598
Views: 8,695

Dear Jay,

❝ In pilot study results of a modified release molecule, the CV obtained for AUC5-t is 114% and the T/R is around 88%.

❝ Can one use CV for more than 100% i.e. 114% in above case for the calculation of pivotal sample size.

If you believe in that CV's, i.e. all was OK with the study conduct:
Why not?

There is not theoretical bound in the CV, beside it has to be > zero.

—
Regards,

Detlew

Complete thread:

Sample size with CV more than 100% Jay 2015-11-02 10:47
- Why not?d_labes 2015-11-02 11:08
  - Why not? Jay 2015-11-02 11:29
    - Sample size for HVD's d_labes 2015-11-02 13:06
      - EMA: MR – ABEL for partial AUCs Helmut 2015-11-02 14:35
        
        EMA: MR – ABEL for partial AUCs d_labes 2015-11-02 14:48

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