Bioequivalence and Bioavailability Forum

Hi Unique_One,

❝ N=16 for fasting pilot…

❝ Parameter     Ratios  CI 90_L  CI 90_U  Power   IS CV (%)

❝ Ln(Cmax)      98.58    77.47   128.41   0.4194   43.13

❝ Ln(AUC last)  93.86    82.05   110.32   0.8307   22.51

❝ Ln(AUC INF)   89.75    72.47   111.56   0.5223   33.65

I fail to understand your numbers. The PE should be \(\sqrt{CL_{lower} \times CL_{upper}}\), right? Based on the CIs I got:

               PE    CV%   “power”
ln(Cmax)     99.74  42.30  0.0472
ln(AUClast)  95.14  24.11  0.5496
ln(AUCinf)   89.92  35.70  0.0997

Strange. Bizarre rounding? BTW, the useless “power” is completely wrong. Shall I say as usual? Is there an Indian con­spiracy to apply a false and outdated method (see this post)? There is a rule of thumb for T/R 0.95 and ≥80% power: n=20 (CV 20%) and n=40 (CV 30%). So why would one expect 83% power for AUClast for n=16? With your reported numbers you would need 26.