## CVintra in replicate designs (→ 2 IBDs) [General Sta­tis­tics]

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.

• If no (two test products in a pivotal study), see slide 23. I strongly recommend to apply Bonferroni’s adjustment (α 0.025 → 95% CI). Again evaluated by two IBDs and CVs calculated as above.

Dif-tor heh smusma 🖖
Helmut Schütz

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