clinicalservices
☆    

India,
2021-01-05 08:19
(158 d 04:04 ago)

Posting: # 22175
Views: 863
 

 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
★★★
avatar
Homepage
Vienna, Austria,
2021-01-05 10:38
(158 d 01:46 ago)

@ clinicalservices
Posting: # 22176
Views: 715
 

 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
[image]

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

NJ,
2021-01-06 00:11
(157 d 12:13 ago)

@ clinicalservices
Posting: # 22179
Views: 682
 

 Intra Subject Variability

Hi,

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

Why steady state?

J
Activity
 Admin contact
21,518 posts in 4,498 threads, 1,523 registered users;
online 12 (0 registered, 12 guests [including 5 identified bots]).
Forum time: Saturday 13:24 CEST (Europe/Vienna)

If I find 10,000 ways something won’t work, I haven’t failed.
I am not discouraged, because every wrong attempt discarded
is another step forward.    Thomas Alva Edison

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5