Bioequivalence and Bioavailability Forum

Dear KR,

❝ As per the code defined in US FDA guideline we define ALPHA as 0.10 in ESTIMATE statement of PROC MIXED for replicate study designs.

Yes you are right....

❝ While we do not define any such statement and use default ALPHA = 0.05 for non-replicate crossover studies with PROC GLM or MIXED procedures.

❝ In both type of studies (replicate or non-replicate), we need to present 90% CI interval.

For the calculation of 90% CI we have to take alpha=0.1 ow it won't be 90% CI's
In PROC GLM we don't have a option to calculate CI's in estimate statement so we have to use formula of CI's for the calculation and there we assign 0.1 as a value of alpha.

Sinhmar