Bioequivalence and Bioavailability Forum • PE consideration

PE consideration [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2013-09-11 14:07 (4672 d 11:05 ago) – Posting: # 11475
Views: 8,647

Dear Jay
what about the third parameter, the intended power?

Formulation difference  5%, CV% 25,   intended Power 80% ⇒ n=28

Formulation difference  5%, CV% 27.5, intended Power 80% ⇒ n=34

Formulation difference  5%, CV% 25,   intended Power 90% ⇒ n=38

Formulation difference 10%, CV% 25,   intended Power 80% ⇒ n=56

Formulation difference 10%, CV% 27.5, intended Power 90% ⇒ n=92

At the end you have to perform a risk/cost evaluation.
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Sample size vasup 2013-07-29 08:37
- Sample size ElMaestro 2013-07-29 10:00
- Sample size jag009 2013-07-29 15:57
- Overpowering Helmut 2013-07-30 15:51
  - Overpowering ElMaestro 2013-07-30 16:37
    - Overpowering jag009 2013-07-30 16:45
      - Overpowering ElMaestro 2013-07-30 16:51
        
        Overpowering jag009 2013-08-01 20:08
        
        Overpowering kumarnaidu 2013-09-02 12:22
        
        Conservative study planning Helmut 2013-09-02 12:42
        
        Conservative study planning kumarnaidu 2013-09-02 14:36
        
        Conservative study planning Ohlbe 2013-09-02 18:44
        
        confidence limit of the CV Jay 2013-09-06 13:55
        
        CL of CV Helmut 2013-09-06 15:02
        
        CL of CV Jay 2013-09-06 15:21
        
        CL of CV Helmut 2013-09-06 15:42
        
        PE consideration Jay 2013-09-11 11:02
        
        PE considerationDr_Dan 2013-09-11 12:07
        
        PE consideration Jay 2013-09-11 13:09
        PE consideration kumarnaidu 2013-09-11 13:22
        
        Sockpuppet? Helmut 2013-09-11 14:13
        PE consideration kumarnaidu 2013-09-12 13:04