Bioequivalence and Bioavailability Forum • N calculation for trial about PK superiority

N calculation for trial about PK superiority [Power / Sample Size]

posted by dshah – India, 2022-09-02 13:52 (966 d 10:27 ago) – Posting: # 23262
Views: 3,980

Hi Alex!

I am wondering why PK superiority? I am not getting if you do not prove faster onset of action with PD superiority, you can have advantage. Already the discussion for Tmax assessment (EMA PSG) is discussed in forum. Could you provide more details for not focusing on PD superiority?
Regards,
Divyen Shah

Complete thread:

N calculation for trial about PK superiority alejandro_jo1990 2022-09-01 14:40
- Bracketing approach Helmut 2022-09-01 15:02
  - SmPC change is the whole thing alejandro_jo1990 2022-09-01 16:18
- N calculation for trial about PK superioritydshah 2022-09-02 11:52
  - The efocus is faster absorption alejandro_jo1990 2022-09-02 18:57
    - The efocus is faster absorption Helmut 2022-09-03 00:46
      - Non-parametric N alejandro_jo1990 2022-09-06 00:26
        
        Non-parametric N Helmut 2022-09-06 17:02
        
        Non-parametric N alejandro_jo1990 2022-09-15 14:56