clinicalservices
☆

India,
2021-01-05 08:19
(128 d 20:53 ago)

Posting: # 22175
Views: 778

## Intra Subject Variability [General Sta­tis­tics]

Dear Members,

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.
Thank you all in advance.

Regards.
Helmut
★★★

Vienna, Austria,
2021-01-05 10:38
(128 d 18:35 ago)

@ clinicalservices
Posting: # 22176
Views: 648

## CVintra in replicate designs (→ 2 IBDs)

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
jag009
★★★

NJ,
2021-01-06 00:11
(128 d 05:02 ago)

@ clinicalservices
Posting: # 22179
Views: 615

## Intra Subject Variability

Hi,

» We are planning to conduct Steady State study having study design as- T1, T2, R, R.