Three way Pivotal bioequivalence study [Design Issues]

posted by Mahesh M – India, 2014-05-30 08:45 (4408 d 01:20 ago) – Posting: # 13018
Views: 4,345

Dear all,

Is it possible to demonstrat of Three way Pivotal bioequivalence study, Two reference (from different regulatory) and one test ?

I would like to ask can we submit the same three way study to different regulatory like US FDA and TGA?


Regards
Mahesh

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