Purpose? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-07-09 13:56 (142 d 13:22 ago) – Posting: # 21666
Views: 1,526

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 🖖
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
21,216 posts in 4,427 threads, 1,481 registered users;
online 20 (0 registered, 20 guests [including 8 identified bots]).
Forum time: Sunday 02:18 CET (Europe/Vienna)

Half the harm that is done in this world
Is due to people who want to feel important.    T. S. Eliot

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