clinicalservices
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India,
2021-01-05 09:19
(1201 d 11:38 ago)

Posting: # 22175
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 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
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Vienna, Austria,
2021-01-05 11:38
(1201 d 09:19 ago)

@ clinicalservices
Posting: # 22176
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 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.

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jag009
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NJ,
2021-01-06 01:11
(1200 d 19:46 ago)

@ clinicalservices
Posting: # 22179
Views: 1,846
 

 Intra Subject Variability

Hi,

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


Why steady state?

J
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