Study Results [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2015-04-21 01:47 (3581 d 06:28 ago) – Posting: # 14722
Views: 12,511

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

Complete thread:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,667 registered users;
157 visitors (0 registered, 157 guests [including 10 identified bots]).
Forum time: 07:15 CET (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

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