Purpose? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-07-09 13:10 (569 d 02:02 ago) – Posting: # 21664
Views: 2,603

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
21,858 posts in 4,574 threads, 1,554 registered users;
online 25 (0 registered, 25 guests [including 15 identified bots]).
Forum time: Saturday 14:13 CET (Europe/Vienna)

Truth in science can be defined as the working hypothesis best suited
to open the way to the next better one.    Konrad Lorenz

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