Bioequivalence and Bioavailability Forum • CVinter (or CVtotal) from CVintra

CVinter (or CVtotal) from CVintra [Power / Sample Size]

posted by john john – Spain, 2015-05-14 14:16 (4054 d 23:02 ago) – Posting: # 14815
Views: 14,305

Hi Helmut

In a bioavailability study with six healthy volunteers:

...(Cmax; range 135–422 ng ml^-') and time to maximum (tmax; range 1.5–7.0 h) for the three tablet doses showed significant differences between subjects (P <0.009; between subject coefficients of variation (CVs) 34% and 27%, respectively). There were no within subject differences in C, (P = 0.32; mean within subject CV 11%

To calculate the sample size for a parallel study I use the total CV= 45?

or do I need the pooled variability? Which is?

Thanks

Edit: Merged with a later post. Don’t fork; you can edit your post with 24 hours. [Helmut]

Complete thread:

Extrapolation john john 2015-05-13 13:36
- CVinter (or CVtotal) from CVintra Helmut 2015-05-13 14:33
  - CVinter (or CVtotal) from CVintra nobody 2015-05-13 14:53
    - OT: Drug Res Helmut 2015-05-13 15:11
      - OT: Drug Res nobody 2015-05-13 15:18
        
        completely OT Helmut 2015-05-13 15:29
        
        completely OT nobody 2015-05-13 15:37
  - CVinter (or CVtotal) from CVintrajohn john 2015-05-14 12:16
    - CVtotal ≠ CVintra + CVinter Helmut 2015-05-15 13:05
      - CVtotal ≠ CVintra + CVinter john john 2015-05-15 13:13
        
        CVtotal ≠ CVintra + CVinter Helmut 2015-05-15 13:14
        
        CVtotal ≠ CVintra + CVinter john john 2015-05-15 13:50
        
        CVtotal ≠ CVintra + CVinter Helmut 2015-05-15 14:07
        
        CVtotal ≠ CVintra + CVinter john john 2015-05-15 15:07
        
        CVtotal ≠ CVintra + CVinter Helmut 2015-05-15 15:10