Bioequivalence and Bioavailability Forum

Hi clinicalservices,

» We are planning to conduct Steady State study having study design as- T1, T2, R, R.
» What should be our approach for calculation of Intra subject variability for such study design.

What’s the purpose of the study – a pilot study to select either T1 or T2 for a pivotal study?
If yes, see this presentation (slide 22).

Estimate \(\small{CV_\textrm{intra,1}=\sqrt{\exp(MSE_1)-1}}\) and \(\small{CV_\textrm{intra,2}=\sqrt{\exp(MSE_2)-1}}\) from the respective residual mean squares errors \(\small{(MSE_i})\) of the two incomplete block designs containing (1) T1 and R and (2) T2 and R.