Bioequivalence and Bioavailability Forum • 🇦🇹 AGES

🇦🇹 AGES [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2024-07-24 13:16 (52 d 09:47 ago) – Posting: # 24097
Views: 1,100

Hi Mittyri,

oh dear!

The presence of period, sequence, and treatment effects were evaluated.

Why the heck?

For AUC_0-t, a significant treatment effect was observed for ASA (p = 0.0221).

So what?

The lower and upper limit of the CI was below 100% …

A consequence of p < 0.05.

… but within the lower limit of the acceptance range of 80.00[%]

Again: So what?
Similar nonsense for SA.

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Complete thread:

FDC with ascorbic acid qualityassurance 2024-07-23 08:08 [Regulatives / Guidelines]
- FDC with ascorbic acid Ohlbe 2024-07-23 09:55
  - FDC with ascorbic acid qualityassurance 2024-07-23 10:13
    - Placebo? Helmut 2024-07-23 12:39
      - Placebo? mittyri 2024-07-23 14:54
        
        🇦🇹 AGESHelmut 2024-07-24 11:16
      - Placebo? qualityassurance 2024-07-24 11:37
        
        Sorry – wrong addressee Helmut 2024-07-24 13:31
        
        lucky mittyri 2024-07-24 16:01

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