Bioequivalence and Bioavailability Forum • The efocus is faster absorption

The efocus is faster absorption [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2022-09-03 02:46 (92 d 10:42 ago) – Posting: # 23264
Views: 846

Hi Alex,

❝ 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

Preliminary stuff in this thread. An introduction in this presentation and more detailed in this article.
Instead of equivalence you are interested in a one-sided test.

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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 absorption alejandro_jo1990 2022-09-02 18:57
    - The efocus is faster absorptionHelmut 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