Treatment effect justification [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2020-10-07 10:19 (345 d 05:18 ago) – Posting: # 21974
Views: 1,243

Hi Siva Krishna,

something like this:

"The test producing a significant treatment effect is that log(y)T=log(y)R where y is the dependent variable (AUC or Cmax). This is not the hypothesis evaluated for the conclusion of bioequivalence. It is entirely expected that Test and Reference could be associated with different levels of (logarithmic) Cmax or AUC as they are truly two different formulations. What the evaluation for bioequivalence shows is that the difference in rate and extent and absorption does not differ by a clinically relevant margin, where clinical relevance is determined by the regulatory convention. Therefore the significant formulation effect does not translate, in this case, into inability to conclude bioequivalence."

Good luck.:-)

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,684 posts in 4,534 threads, 1,541 registered users;
online 13 (1 registered, 12 guests [including 3 identified bots]).
Forum time: Friday 15:37 CEST (Europe/Vienna)

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

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