Bioequivalence and Bioavailability Forum • The efocus is faster absorption

The efocus is faster absorption [Power / Sample Size]

posted by alejandro_jo1990 – Spain, 2022-09-02 20:57 (92 d 17:49 ago) – Posting: # 23263
Views: 857

❝ 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?

Hi Diven thanks for the answer!
If you have the link to the thread reagarding the Tmax discussion, could you paste it here please? Regarding the issue, the want to demonstrate faster absorption not faster onset of action, therefore the whole discussion about if AUC, therapeutic ranges etc
BR
Alex

Complete thread:

N calculation for trial about PK superiority alejandro_jo1990 2022-09-01 14:40 [Power / Sample Size]
- 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 superiority dshah 2022-09-02 11:52
  - The efocus is faster absorptionalejandro_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