Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-07-22 23:51 CEST (UTC+2h)

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

posted by bebac_fan - US, 2018-03-28 18:43  - Posting: # 18601
Views: 2,368

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,547 posts in 3,941 threads, 1,190 registered users;
online 19 (0 registered, 19 guests [including 17 identified bots]).

Ignorance more frequently begets confidence
than does knowledge.    Charles Darwin

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed