Flawed evaluation accepted [RSABE / ABEL]

posted by Mikalai  – Belarus, 2020-01-31 12:40 (402 d 03:12 ago) – Posting: # 21117
Views: 13,932

Dear Helmut,

I would like to stress out again that this decision tree has been used in multiple accepted BE studies. The tree is used not only by Indian CROs but CROs from developed countries. Cannot say more because it is a bit confidential. And again no complaints from regulators at all; otherwise, it would not be used


Why is it flawed?
They passed bioequivalence with the first step and did not go to the second one. It may be risky according to your approach but they were lucky enough. There is no TIE inflation in their study as I understand.
What is wrong in relation to TIE inflation?

Best regards

Edit: Merged with a later (now deleted) post. You can edit your posts for 24 hours. [Helmut]

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