[Opinion] Should the 90% CI for GMR be required to encompass 1 [RSABE / ABEL]

posted by jag009  – NJ, 2018-03-29 19:55 (1594 d 01:41 ago) – Posting: # 18619
Views: 8,777

Hi,

» Actually, I am questioning the validity of FDA's Swr scaled 10% window on BE for NTID.
»
» If a GMR of 1.1 is clinically relevant (i.e. a test should be sensitive for this), and the NTID with a Swr of .22 will pass by ABE, this is a failure IMO.

Before we go further, does your hypothetical example pass the other two criteria stated in the NTI guidance?

Complete thread:

UA Flag
Activity
 Admin contact
22,289 posts in 4,666 threads, 1,585 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time: Tuesday 21:37 CEST (Europe/Vienna)

The existing scientific concepts cover always only
a very limited part of reality,
and the other part that has not yet
been understood is infinite.    Werner Heisenberg

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