Purpose? [RSABE / ABEL]

posted by Mithu – India, 2020-07-09 11:22 (34 d 09:39 ago) – Posting: # 21665
Views: 1,133

Dear Sir,

» 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. Contrary to ABEL (used in all jurisdictions for reference-scaling except in the US and China) assessing ‘outliers’ is not acceptable for RSABE.

Actually Sir, we do not have SAS at our end (sponsor) but now i got the point that such verification will not help in excel.

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

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

CRO runs on SAS and providing PK sheet of data in excel to us and i was checking with excel. But today i got the correct way and understand how the software calculate ratio.

Regards,

Mithu.

Complete thread:

Activity
 Admin contact
21,008 posts in 4,379 threads, 1,460 registered users;
online 36 (0 registered, 36 guests [including 10 identified bots]).
Forum time: Wednesday 21:02 UTC (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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