Bioequivalence and Bioavailability Forum

clinicalservices ☆ India, 2021-01-05 09:19 (1347 d 10:11 ago) Posting: # 22175 Views: 3,022	Intra Subject Variability [General Statistics] Post reply
	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 11:38
(1347 d 07:52 ago)

@ clinicalservices
Posting: # 22176
Views: 2,369

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 ★★★ NJ, 2021-01-06 01:11 (1346 d 18:19 ago) @ clinicalservices Posting: # 22179 Views: 2,370	Intra Subject Variability Post reply
	Hi, ❝ We are planning to conduct Steady State study having study design as- T1, T2, R, R. Why steady state? J