Bioequivalence and Bioavailability Forum • PowerTOST and Sample size estimation for R-SABE

PowerTOST and Sample size estimation for R-SABE [RSABE / ABEL]

posted by Dr_Dan – Germany, 2014-04-18 21:29 (4456 d 00:15 ago) – Posting: # 12859
Views: 19,027

Dear Kumar Naidu
To get things clear: You are the sponsor of the study and the CRO is the service provider. If you have a reasonable sample size estimation and if you want to pay for 66 subjects then the CRO should perform the study as you suggest unless they have reasonable objections. In case you anticipate a formulation difference of <5% and a power of 80% then the sample size solely depends on the intra-subject variability. This variability is not carved in stone. It is up to you to assume if the true value is rather 42% or 34%.
At the end it is the responsibility of the sponsor.
I hope this helps.
Kind regards
Dr_Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Sample size calculation for R-SABE Lucas 2014-02-07 11:41
- EMA’s ABEL Helmut 2014-02-07 14:21
  - EMA’s ABEL Lucas 2014-02-07 16:49
    - Carry-over Helmut 2014-02-07 17:12
      - Carry-over Lucas 2014-02-07 17:42
        
        Carry-over Shuanghe 2014-02-10 17:11
- PowerTOST and Sample size estimation for R-SABE d_labes 2014-02-07 14:37
  - PowerTOST and Sample size estimation for R-SABE kumarnaidu 2014-04-18 13:38
    - PowerTOST and Sample size estimation for R-SABEDr_Dan 2014-04-18 19:29
      - PowerTOST and Sample size estimation for R-SABE kumarnaidu 2014-04-19 06:04
  - PowerTOST and Sample size estimation for R-SABE Astea 2015-06-25 01:14
    - Sample size for scABEL/RSABE vs. conventional ABE d_labes 2015-06-25 09:19
    - PowerTOST and Sample size estimation for R-SABE mittyri 2015-06-25 10:43
      - PowerTOST and Sample size estimation for R-SABE Astea 2015-06-25 13:54
        
        Scaled ABE d_labes 2015-06-25 14:04