Setup in Phoenix/WinNonlin [Study As­sess­ment]

posted by AngusMcLean – USA, 2016-05-15 15:17  – Posting: # 16306
Views: 16,451

Helmut: I am having difficulty with Phoenix: I get an error message when the program loads relating to a missing framework. It tells me that the program may not work properly. However I have been able to get your file to run OK eventually. It is a dose escalation study....very early development. No study design per se is given. After this success I then tried the data set I have already studied for dose proportionality by dose-normalized BE in Phoenix. There are only two doses given to 20 subjects cross-over design. So using your structure I set up the input for LME model. The model was lndose as given by you. I was able to get an evaluation for residual error for both Cmax and AUC0-t. The values were indeed very similar to what I had obtained in PHoenix (e.g. Cmax CV(%) was 19.9 compared with 20.06 (BE result). The CV(%) for AUC0-t ws 12.2 compared with 12.6% by BE approach). Other worker has reported CV(%) of 0.1 for AUC0-t. I am wondering if using SAS you can get a result of 0.1. For Cmax other worker reports CV% 10.1. I do not think using SAS can give such a difference?

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