Bioequivalence and Bioavailability Forum • Nitrofurantoin BE study

Nitrofurantoin BE study [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2015-08-28 11:15 (3156 d 23:27 ago) – Posting: # 15361
Views: 9,460

Dear PJS
You already gave the answer yourself to your question regarding the possible request of statistical evaluation of tmax: rapid release is not clinically relevant in this case and statistical evaluation of tmax is not required. Why be so afraid? tmax is no primary parameter and of course you have to present descriptive statistics but nothing more. Orally administered Nitrofurantoin is readily absorbed in the upper gastrointestinal tract and if there are significant differences in tmax between your formulation and the originator you may fail to demonstrate BE for Cmax.
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 studyDr_Dan 2015-08-28 09:15
      - Nitrofurantoin BE study pjs 2015-08-28 10:37
        
        Nitrofurantoin BE study Dr_Dan 2015-08-31 18:19
        
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