Bioequivalence and Bioavailability Forum • CL of CV

CL of CV [Regulatives / Guidelines]

posted by Jay – India, 2013-09-06 17:21 (4676 d 04:52 ago) – Posting: # 11452
Views: 8,808

Thanks Helmut.

Is this method i.e. Upper CI of CV, should be considered while calculating sample size everytime? We use highest CV of Cmax, Auc0-t or AUCinf observed in pilot or from any literature.

And is this use of upper CI of CV in sample size calculation commonly used in BE Studies? As much unawareness about its usage in Sample size calculation is not here.

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 CVJay 2013-09-06 15:21
        
        CL of CV Helmut 2013-09-06 15:42
        
        PE consideration Jay 2013-09-11 11:02
        
        PE consideration Dr_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