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

posted by bebac_fan – US, 2018-03-28 20:43 (1826 d 12:57 ago) – Posting: # 18601
Views: 10,359

Dear All -

I am a new poster, long time lurker. I am a clinical pharmacologist who is crazy (but not formally trained) about statistics.

My question involves the case where an entire GMR 90% confidence interval is outside of 100.00 (e.g. 103.00 - 110.00). For HVD with wide therapeutic index, I believe this is reasonable. But what about for a NTID with doses that differ by less than 15%?

I understand this is part of the reason that RSABE and ABEL are implemented. However, let us assume that the Swr is 22% and essentially expands reference scaling to ABE limits. Let us also assume that a 7% difference in BE is clinically significant.

In your opinion, is it reasonable to require the 90% CI for GMR to fall within 1?

Thanks,
bebac_fan

Complete thread:

UA Flag
Activity
 Admin contact
22,557 posts in 4,724 threads, 1,607 registered users;
26 visitors (0 registered, 26 guests [including 11 identified bots]).
Forum time: 09:40 CEST (Europe/Vienna)

The function of genius is not to give new answers, but to pose
new questions which time and mediocrity can resolve.    H.R. Trevor-Roper

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