Bioequivalence and Bioavailability Forum

Hi All,

Hope all of you are doing well.

I have 2 questions regarding 2 treatment 3 period 3 sequence BE study:

1) How to calculate CVintra and CVinter for Cmax using proc GLM;

(According to my knowledge; in 2*2*2 we use proc mixed and we use Residual to get CVintra and Subject(Sequence) to get CVinter using the following formulas):

CVintra= 100*sqrt(exp(y)-1);
CVinter= 100*sqrt(exp(x)-1);

However, In proc GLM, I don't get the residual value to use in CVintra equation as I know that if CVintra > 30%, we have to use proc glm no proc Mixed. The code I am using for proc GLM is:

ods html;
proc glm data=ee;
class subject treat per sequence;
model auc0_t=treat per sequence subject(sequence);
random subject(sequence);
means treat /hovtest=levene(type=abs);
output out=resids r=residual;
run;

Using this, I get the sum of the squared residuals but I dont know which to use?!!.

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Merged from follow-up post [Helmut]:

Can any one tell me how can I get the CVinter and CVintra for Partial replicate (2*3*3).

I followed the code by FDA for partial replicate and I got ilat and dlat and I know the difference between both of them.

However, I don't get the subject(sequence) to use for Cvinter and I don't know which value to use for Cvinter?

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2) For Outlier Analysis using Residuals, Do I have to check for the outliers of each parameter separated? As for example; In AUC0-INF I have missing data values. However, in AUC0-T and Cmax I have no missing ones.

Thanks.

Yours,
M.Yehia

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Edit: Relax; see also this post #8. 21 hours ≠ 14 days. You can edit you original post for 24 hours; see there. Follow-up post deleted. [Helmut]