No significance testing in BE [Nonparametrics]

posted by Helmut Homepage – Vienna, Austria, 2018-06-20 13:24 (2134 d 00:22 ago) – Posting: # 18928
Views: 8,095

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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,990 posts in 4,826 threads, 1,665 registered users;
55 visitors (0 registered, 55 guests [including 5 identified bots]).
Forum time: 13:46 CEST (Europe/Vienna)

If you don’t like something change it;
if you can’t change it, change the way you think about it.    Mary Engelbreit

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5