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

posted by bebac_fan – US, 2018-03-29 18:57 (2654 d 13:12 ago) – Posting: # 18617
Views: 11,793

Dear John

❝ So basically he's questioning the validity of FDA's 20% window on BE then...


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.

Thanks,
BF

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,684 registered users;
81 visitors (0 registered, 81 guests [including 23 identified bots]).
Forum time: 08:09 CEST (Europe/Vienna)

In the field of observation,
chance favors only the mind that is prepared.    Louis Pasteur

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