Estimate of Intrasubject CV from a study with TX effect [General Sta­tis­tics]

posted by zan – US, 2014-01-30 01:08 (4521 d 19:12 ago) – Posting: # 12290
Views: 7,479

All,
My knowledge to obtain an accurate intrasubject CV% is to conduct a replicated crossover design dosing same formulation twice.
From a 2x2 crossover study where signiciant treatment effects exist, eg. a significant food-effect study, we are still able to obtain the intrasub CV% from the output.
As I was going to use these intrasub CV% to help biostats to est sample size for a BE study, someone challenged that these number are not real and are likely inflated due to the signficant treatment effect. Is it true? I am wondering does it invalidate the use of intrasub CV% in studies with significant tx effect or these estimates are still close to those from a replicated study.

Many thanks and best regards

zan


Edit: Category changed. [Helmut]

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