Carry over and statistical adjustment in BE computations [General Sta­tis­tics]

posted by Achievwin – US, 2023-10-02 22:34 (975 d 05:34 ago) – Posting: # 23729
Views: 14,302

If the forum can throw some light on the addressing following points on carry-over.
what I am trying to understand is how to answer - Unequal carryover (between Test and RLD) effect on potential inflation of Type-1 error and bias in the BE conclusions"
  1. How to measure carry-over (any particular PK parameters or in vitro measures?)
  2. How to assess equal or unequal carryover?
  3. Differences in 1st order or other order carry-over
  4. Is there a cut-off to call negligible carry-over
  5. What are the statistical tests to call it a unequal carry-over or no un-equal carry-over.
  6. How to factor or apply any corrections of observed carry-over in BE and RSABE calculations?
I realize these are loaded questions but any true insight that gets buying by EMA or FDA is much appreciated.

Complete thread:

UA Flag
Activity
 Admin contact
23,653 posts in 4,991 threads, 1,571 registered users;
164 visitors (0 registered, 164 guests [including 15 identified bots]).
Forum time: 04:09 CEST (Europe/Vienna)

I’m all in favor of the democratic principle
that one idiot is as good as one genius, but I draw the line
when someone takes the next step and concludes
that two idiots are better than one genius.    Leo Szilard

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