Bioequivalence and Bioavailability Forum

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

posted by Helmut – Vienna, Austria, 2021-01-05 11:38 (1641 d 10:23 ago) – Posting: # 22176
Views: 3,265

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 🖖🏼 Довге життя Україна!
Helmut Schütz

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Science Quotes

Intra Subject Variability clinicalservices 2021-01-05 08:19
- CVintra in replicate designs (→ 2 IBDs)Helmut 2021-01-05 10:38
- Intra Subject Variability jag009 2021-01-06 00:11