Bioequivalence and Bioavailability Forum

Hi,

❝ I assume that the significance level is 0.05.

Note that this is your assumption, not WNL

❝ Does the first row of the effects sheet not indicate a test for sequence effects?

It indicates.

❝ Does the second row of the effects sheet not indicate a test for treatment effects?

It indicates.

❝ Although I also think that the residual effect can not be used as a reason for the interruption test,

❝ However, for this paper, 3.2 and 3.3 depend on 3.1, and only after the 3.1 test is passed, the tests of 3.2 and 3.3 can be performed.

WNL is software, not all-mighty wisdom. Only YOU can decide whenever it is possible to delete residual effects from the model and take into account that rows.

❝ 1. In the effect sheet, the P value judgment of the Treatment is independent of the sequence and the period.

The treatment is dependent on Sequence only, not period, as authors of paper mentioned (see above). It is, IF you cannot neglect unequal carry-over, you cannot test Treatment (3.2), but can try bivariate Wilcoxon statistic (3.4).

❝ 2. All P values in the effect sheet are only statistically significant. The P value has no substantial clinical significance and should not be overly concerned. We should pay more attention to the results in the Confidence Intervals sheet.

It depends on the Hypothesis you are stating in the Protocol.

❝ 3. For the effect sheet, we should pay attention to whether the median of Treatment_Diff_( T - R ) has clinical significance.

and related to the hypothesis you are testing.

❝ 1. For the nonparametric test of Tmax, is the only way to calculate the P value using "Mann–Whitney U test"?

Obiously not. You can use any test aplicable for ordinal data with scientific justification.

❝ 2. For the non-parametric test of Tmax, can we use the "Wilcoxon signed rank test" to calculate the P value?

Sure, you can. Just keep in mind that you are neglecting period/sequence effects. It tests the within-subject treatment differences against zero and is therefore a non-parametric analogon of the paired Student t-test (see the link to the discussion above in the previous post).

❝ 3. For the effect sheet, is the "Conclusion_Diff_(T - R)" confidence interval "0" necessary?

Cannot get the question