Purpose? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-07-09 11:10 (31 d 23:38 ago) – Posting: # 21664
Views: 1,129

Hi Mithu,

» :-) Actually sir when we receive PK data from site (CRO), we check by using Excel. That's why i was using Excel for verification. Generally in average BE and partial replicate, we get it verified but for fully replicate study, i could not match the ratio.
»
» This is the story.

I don’t understand the purpose of this ‘verification’. Calculate the study in SAS. The individual T/R-ratios don’t play any role in RSABE (log-differences are only an intermediate result).
Are you concerned about extreme values? They are common for HVD(P)s. 1 Contrary to ABEL (used in all jurisdictions for reference-scaling except in the US and China) assessing ‘outliers’ 2 is not acceptable for RSABE.


  1. I have seen studies with subject ratios of 0.2–5 (‼) and still passing RSABE.
  2. In ABEL of the reference treatment only.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
20,992 posts in 4,375 threads, 1,460 registered users;
online 16 (2 registered, 14 guests [including 7 identified bots]).
Forum time: Monday 10:48 UTC (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

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