Bioequivalence and Bioavailability Forum

Carry-over [General Statistics]

posted by dshah – India, 2023-10-03 18:34 (642 d 01:03 ago) – Posting: # 23734
Views: 7,077

Dear Achivewin!

❝ Good point...... but CRLs won't leave you without these questions.... somehow regulators seems to be obsessed with that borderline "Carry-over"

How many % of subjects had carryover? If its more than 5% of Cmax, generally the exclusion criteria cover it so that subject is not considered for statistical evaluation. If more than 20% subject has carry over effect (more than 5%Cmax value), than an investigation would be needed but this indicates that washout period was insufficient.
Regards,
Divyen

Complete thread:

Carry over and statistical adjustment in BE computations Achievwin 2023-10-02 20:34 [General Statistics]
- 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-overdshah 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- Outdated and wrong answers mittyri 2023-10-05 20:34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 [General Sta­tis­tics]

Complete thread:

Carry-over [General Statistics]