Bioequivalence and Bioavailability Forum • Nitrofurantoin BE study

Nitrofurantoin BE study [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2015-08-31 20:19 (3545 d 11:32 ago) – Posting: # 15369
Views: 11,324

Dear PJS
Tmax is a secondary endpoint and undergoes only descriptive statistics.
Don´t try to answer questions nobody asked. So keep the study protocol as simple as it needs to be and if a authority raises questions regarding tmax you can still make up your mind. Without knowing the study outcome it is useless to discuss whether differences are clinically relevant and/or statistically significant.
Kind regards
Dr_Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

Nitrofurantoin BE study pjs 2015-07-30 08:55 [Regulatives / Guidelines]
- Nitrofurantoin BE study drgunasakaran1 2015-08-02 14:56
  - Nitrofurantoin BE study pjs 2015-08-03 10:06
- Nitrofurantoin BE study pjs 2015-08-07 04:10
  - Nitrofurantoin BE study pjs 2015-08-27 15:36
    - Nitrofurantoin BE study Dr_Dan 2015-08-28 09:15
      - Nitrofurantoin BE study pjs 2015-08-28 10:37
        
        Nitrofurantoin BE studyDr_Dan 2015-08-31 18:19
        
        Nitrofurantoin BE study AB661 2021-06-15 09:38
        
        Nitrofurantoin BE study Relaxation 2021-06-15 12:10
        
        Nitrofurantoin BE study AB661 2021-06-16 08:13
        
        Nitrofurantoin BE study Relaxation 2021-06-16 12:59