Bioequivalence and Bioavailability Forum

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

posted by Achievwin – US, 2023-10-02 22:34 (550 d 01:50 ago) – Posting: # 23729
Views: 5,576

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"

How to measure carry-over (any particular PK parameters or in vitro measures?)
How to assess equal or unequal carryover?
Differences in 1st order or other order carry-over
Is there a cut-off to call negligible carry-over
What are the statistical tests to call it a unequal carry-over or no un-equal carry-over.
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:

Carry over and statistical adjustment in BE computationsAchievwin 2023-10-02 20:34
- Carry-over → 🚮 Helmut 2023-10-02 21:06
  - Carry-over → 🚮 Achievwin 2023-10-03 12:13
    - Carry-over → 🚮 Helmut 2023-10-03 12:48
    - Carry-over dshah 2023-10-03 16:34
      - Carry-over Achievwin 2023-10-03 20:33
        
        Carry-over Helmut 2023-10-04 08:31
        
        Carry-over Achievwin 2023-10-04 16:38
        
        Carry-over dshah 2023-10-04 11:22
      - more than 20% subject carry over effect investigation mittyri 2023-10-05 20:15
      - carry over effect investigation based on what? Helmut 2023-10-06 07:08
        
        carry over effect investigation based on what? dshah 2023-10-06 13:20
- Outdated and wrong answers mittyri 2023-10-05 20:34
  - Wrong answer Helmut 2023-10-06 07:19

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

Complete thread:

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