No significance testing in BE [Nonparametrics]

posted by Helmut Homepage – Vienna, Austria, 2018-06-20 11:24 (952 d 03:31 ago) – Posting: # 18928
Views: 4,600

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.

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