Common sense instead of statistics [Software]

posted by Helmut Homepage – Vienna, Austria, 2020-04-27 13:45 (946 d 18:49 ago) – Posting: # 21351
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Hi vixen,

❝ I like Helmut's suggestion to assess achievement of SS for individual subjects.


My suggestion dates back to 2007. A while ago…
I don’t use it since 2010 and don’t recommend it any more (see this presentation, slide 14). Furthermore, the EMA stated:*

A specific statistical method to assure that steady state has been reached is not considered necessary in bioequivalence studies. Descriptive data is sufficient.


❝ I wonder though whether I should evaluate the Cpds on a normal or logarithmic scale.


Normal – otherwise you cannot deal with BQLs and missings.

❝ What is your approach?


See the presentation.



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