Purpose? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-07-09 13:10 (310 d 02:26 ago) – Posting: # 21664
Views: 1,947

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
21,462 posts in 4,487 threads, 1,514 registered users;
online 15 (0 registered, 15 guests [including 7 identified bots]).
Forum time: Saturday 15:37 CEST (Europe/Vienna)

By all means let’s be open-minded, but not so open-minded
that our brains drop out.    Richard Dawkins

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