Part II - BEBAC • Consultancy Services for Bioequivalence

6/6 | Statistical Design and Analysis IIIAlgebra…Calculation of CV intra from CI Estimate the number of subjects / sequence (example2×2 cross-over) If total sample size (N) is an even number, assume (!)n 1 = n 2 = ½N If N is an odd number, assume (!)n 1 = ½N + ½, n 2 = ½N – ½ (not n 1 = n 2 = ½N!) Difference between one CL and the PE in log-scale; usethe CL which is given with more significant digits∆ = ln PE − ln CL or ∆ = ln CL − ln PECL lo CL hiinformalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201012 • 68