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

posted by jag009  – NJ, 2018-03-29 21:55 (2250 d 22:37 ago) – Posting: # 18619
Views: 9,834

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
23,035 posts in 4,835 threads, 1,645 registered users;
60 visitors (0 registered, 60 guests [including 8 identified bots]).
Forum time: 20:32 CEST (Europe/Vienna)

That which is static and repetitive is boring.
That which is dynamic and random is confusing.
In between lies art.    John Locke

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