Nitrofurantoin BE study [Regulatives / Guidelines]

posted by pjs – India, 2015-08-27 15:36 (2588 d 16:21 ago) – Posting: # 15359
Views: 8,837

Dear all,

Apologies for the consecutive post.

» Please suggest statistical evaluation of tmax is required in this BE study or not.

Pls share your views for the mentioned.

How to decide what is clinically relevant and what is not?

What is the usual practice? to keep the Statistical evalution of Tmax or not?

What justification can be given if statistically significant diff is found between Tmax of test and ref but BE criteria is fulfilled in terms of Cmax nad AUC.

Regards,
PJS

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