Bioequivalence and Bioavailability Forum

Dear All,

I have a discussion point for Tmax analysis using NP test.

I have calculated the significant p-value for Tmax on replicate data (T R T R) by splitting in T1 R1 and T2 R2. Diffecrence1= T1-R1 and Diffecrence2= T2-R2. I have used NP test on these differences.

First is it a correct approach logically?

As i assume, tmax is nothing but a one of the protocol time point, not a derived data. So i did not calculated the average of T1&T2 and R1&R2 = T-R.

Second, i am getting p-value significant. How to interpret the data then?
I have used total 80 subjects; out of these 60 subjects have tmax value same for both Test and reference (i.e. T1 R1 and T2 R2). As a result, differences are zero for 60 subjects.

NP test was performed by using wilcoxon signed rank test, so no rank will be assigned to these 60 subjects as their diff are zero. Only 20 subjects have non-zero value and are very much vary from each other, due to this i am getting p-value significant.

From data, my 60 out of 80 subject have Tmax value of test product similar to reference. This is good actually. But from NP test, p-value is significant. How to handle this case?
Is there any guideline recommendation?

Your suggestions are most welcome.

Regards,
Sudy

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Edit: Category changed; see also this post #1. [Helmut]