Nitrofurantoin BE study [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2015-08-31 18:19 (2538 d 21:10 ago) – Posting: # 15369
Views: 8,296

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

Kind regards and have a nice day
Dr_Dan

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