Bioequivalence and Bioavailability Forum • PE consideration

PE consideration [Regulatives / Guidelines]

posted by Jay – India, 2013-09-11 13:02 (4673 d 11:42 ago) – Posting: # 11474
Views: 8,808

Dear Helmut,

Can we consider CV from a range, i.e. we got 24.7 CV from pilot and literature reports as high as 30. So can we use Cv of 26 or 27 for sample size calculation?

And also we got point estimate of 1.06. So can we use 1.06 PE in our sample size calculation. Can we also use PE from literature, we observed PE of 1.08. Or we have to stick to 0.95 to 1.05%?

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 considerationJay 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