Purpose? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-07-09 15:56 (939 d 21:17 ago) – Posting: # 21666
Views: 3,162

Dear Mithu,

❝ Actually at present i prepared excel for one of the our HVD and just learning how the data are interpreted.

I have strong doubts that is possible to set up the FDA’s mixed-effects model for ABE in Excel. I would never ever rely on its Solver Add-in.

❝ CRO runs on SAS …

❝ Now i suggest my management to equipped us with proper tool to verify data correctly at our end.

Trust, but verify.    (Russian proverb)

You would need SAS, JMP, or Phoenix WinNonlin (maybe SPSS, Stata, STATISTICA). Don’t know which one is the least expensive. Only for SAS and Phoenix WinNonlin free code is available. For the others you are on your own.

BTW, why are you regularly ignoring some of my questions? Still open:

❝ ❝ Are you concerned about extreme values? They are common for HVD(P)s. Contrary to ABEL (used in all jurisdictions for reference-scaling except in the US and China) assessing ‘outliers’ is not acceptable for RSABE.

What will you do (or have done in the past) with your ‘verification’? The T/R-ratios are not part of the RSABE SAS-output provided by the CRO.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

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

Complete thread:

UA Flag
 Admin contact
22,478 posts in 4,708 threads, 1,604 registered users;
10 visitors (0 registered, 10 guests [including 8 identified bots]).
Forum time: 12:13 CET (Europe/Vienna)

If you don’t like something change it;
if you can’t change it, change the way you think about it.    Mary Engelbreit

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