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

Regards


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]

Complete thread:

Activity
 Admin contact
21,371 posts in 4,463 threads, 1,495 registered users;
online 12 (0 registered, 12 guests [including 4 identified bots]).
Forum time: Monday 15:53 CET (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5