## No significance testing in BE [Nonparametrics]

Hi libaiyi,

no idea about SAS.

Phoenix:
Test                   T_stat    p_value  Treatment|(SEQ1=SEQ2)    46    0.39727171

My R-code:
Expectation   : 52.5 Statistic     : 46 Exact         : Z = -0.84650388, p-value = 0.41491841 Asymptotic    : Z = -0.84650388, p-value = 0.39727171

» So, which p value should I take as the decision standard for the test?

Generally I prefer an exact test over an asymptotic one.
Significance testing is of historic interest in BE only (was abandoned decades ago). You should pre-specify an interval which you consider to be not relevant from a clinical perspective. For tmax of a pain-killer it might be just ±20 minutes but for a modified release product which is only used in steady state even a couple of hours. At the end assess whether the CI of the difference lies within the interval as usual.

Dif-tor heh smusma 🖖
Helmut Schütz

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