Nitrofurantoin BE study [Regulatives / Guidelines]

posted by pjs – India, 2015-08-28 10:37 (2211 d 10:51 ago) – Posting: # 15362
Views: 7,443

Dear Dr_Dan,

Many thanks for your suggestion.

As a sponsor we have recieved some BE protocols of diff products from the CRO for review. The usual practice of the CRO is that they analyse median difference of Tmax by nonparametric Wilcoxon test for all the Products. As per my understanding this evaluation is only necessary in case of clinical relevance and should not be included in all the protocols. But i am confused what to consider clinically relevant and what not. I think analgesic drugs fall under this catgory but what about other class of drugs?

I am afarid if the sample size is small in the study, then smaller diff between test and ref product Tmax may come as statistically significant although BE criteria may be fulfilled for AUC and Cmax (is this possible or if there is statistically significant diff between Tmax then Cmax must fail BE criteria).

Regards
PJS

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