Nitrofurantoin BE study [Regulatives / Guidelines]

posted by Dr_Dan  – 2015-08-28 09:15 (2292 d 07:17 ago) – Posting: # 15361
Views: 7,870

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

Kind regards and have a nice day

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