Second opinion (PHX 6.3) [RSABE / ABEL]

posted by jag009  – NJ, 2013-05-01 17:16 (2976 d 05:59 ago) – Posting: # 10518
Views: 18,139

Thank you Helmut!

Detlew, need help! :-)

Here is the covariance output from SAS on ln AUCt

Covariance Parameter Estimates
Cov Parm  Subject       Group         Estimate
FA(1,1)   subject                     0.4427
FA(2,1)   subject                     0.4236
FA(2,2)   subject                     0.2481
Residual  subject   formulation Ref   0.05301
Residual  subject   formulation Test  0.02648

Question, what does the residual "formulation Test" represent? Is it the residual attributed to both test and ref, while residual "formulation ref" is attributed to the ref (since it was given 2x)? which one would one use to compute the 90% geometric CI then?

» IMHO, since a partial replicate according to FDA’s model is always (!) overspecified there is no guarantee that the LME-engines will converge. Don’t blame SAS and PHX; they warn us… Stupid design. If you want to have only three periods maybe it is better to run a fully replicated design (TRT|RTR) in the future.

Any hint on the stat approach?


Complete thread:

 Admin contact
21,540 posts in 4,502 threads, 1,525 registered users;
online 10 (0 registered, 10 guests [including 6 identified bots]).
Forum time: Thursday 23:16 CEST (Europe/Vienna)

Laws are like sausages – it is better
not to see them being made.    Otto von Bismarck

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