Study Results [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2015-04-21 01:47 (3265 d 12:54 ago) – Posting: # 14722
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Hi VSL,

❝ Please explain what to do if following results obtained in BE-Study:

❝ 1. Study is passed in CI but mean T/R ratio is not within the 0.80-1.25.


This does not correspond to the world I know. Can you show the example?
If I am not mistaken HRotter or some other guru once mentioned on this forum that a PE outside the CI is theoretically possible; from the equation for the 90% BE CI -which I hope is generally accepted- I think it is evident that the PE is not outside the CI.

❝ 2. Study is passed in CI but there is significant p-value for treatment/period/sequence


The term is nuisance effect. This forum has discusssed it many times, try and search for it. Basically, it should not be too much of a worry. Those p-values correspond to a null hypothesis you are not really interested in when testing for BE.
Pre-dose levels of the analyte is, however, more tangible ground for concern.

Pass or fail!
ElMaestro

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