ABE for partial replicate design acc. to the FDA [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2025-12-30 12:11 (172 d 10:45 ago) – Posting: # 24544
Views: 1,897

Hi Shuanghe,

❝ I must've been :sleeping:

You are awake! This function is undocumented. Thus you don’t find it in the man-pages – only in the sources on GitHub: https://github.com/Detlew/PowerTOST/tree/master/R.

❝ Your mention of chatGPT reminds me that we still haven't been able to reproduce the FDA's unscaled ABE using the […] SAS code, which was also summarised in one of Helmut's post.

It would be interesting whether it would be possible with Pumas* for Julia. At least it is claimed in this tutorial. Perhaps useful as well:
https://github.com/camontefusco/pumas-bioequivalence-course-project-reference-scaling-and-narrow-therapeutic-index-drugs
Pumas is free for Academic Research & Training. Don’t know the costs of a commercial license.

❝ Maybe we can ask chatGPT to come up with R code to reproduce the result from SAS? I'll play it when I got some time and report back here.

Good luck!



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