Purpose? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-07-09 11:10 (141 d 20:15 ago) – Posting: # 21664
Views: 1,524

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

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