Bioequivalence and Bioavailability Forum • Parallel BE

Parallel BE [Power / Sample Size]

posted by drcampos – Brazil, 2012-04-10 18:11 (5194 d 17:10 ago) – Posting: # 8401
Views: 10,196

Dear All,

I would like to know if it is possible to calculate the CV total considering the point estimate (PE) and the confidence limits of a parallel BE study. For this study Cmax - PE = 1.08 and CI = 0.82-1.18. Number of volunteers = 122.

Another information is the root mean square error, Cmax = 0.592

I would like to confirm if a number of volunteers of 126 would be adequate for a parallel BE study considering these information.

Thank you in advance.

best regards, Daniel

Complete thread:

Parallel BEdrcampos 2012-04-10 16:11
- Parallel BE Helmut 2012-04-10 17:20
  - Parallel BE drcampos 2012-04-10 21:03
    - FDA’s review Helmut 2012-04-11 02:22
      - A reviewer which doesn't review isn't a good reviewer d_labes 2012-04-11 09:57
        
        14 months for 1st review Helmut 2012-04-11 13:51
        
        Guidelines - nonbinding, Scientific advice - nonbinding … d_labes 2012-04-11 15:50
        
        Grumpy ol’ men Helmut 2012-04-11 16:22
        
        Grumpy ol’ men - OT d_labes 2012-04-11 17:04
        
        GDR - OT Helmut 2012-04-11 17:47