Qualitative analysis of the ANOVA residuals [General Sta­tis­tics]

posted by Lucas – Brazil, 2014-02-19 15:58 (2408 d 06:52 ago) – Posting: # 12453
Views: 16,608

Hi Helmut! Thanks for the fast response, as always.

» ANVISA?

No, the sponsor wants us to perform that. The study would be submitted at ANVISA, but I think they want a study that can be (if they ever need) submitted at other agencys. I just love how they ask us that kind of analysis without even explaining their objective with that. So I thought that you guys had experience with that being required in other countries. The sponsor is from England, if that helps.

» IMHO, assessing the studentized residuals makes sense. See also Canada’s Guidance, Section 2.3.4.

Doesn't seem to be a criteria for saying if the results are good or not, am I right?

» [...] and with a little bit of struggle – in Phoenix/WinNonlin.

Can u tell me how it can be done at Phoenix?

Thanks.

Complete thread:

Activity
 Admin contact
21,072 posts in 4,394 threads, 1,468 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Wednesday 23:51 CEST (Europe/Vienna)

The important thing in science is not so much to obtain new facts
as to discover new ways of thinking about them.    William Henry Bragg

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