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

posted by Achievwin – US, 2023-10-02 22:34 (57 d 12:33 ago) – Posting: # 23729
Views: 1,291

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.

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