SS indication for dataset with BID dose and AM dose different from PM dose.

From: Kim Stuyckens Date: July 11, 2006 technical Source: cognigencorp.com
From: "Stuyckens, Kim [PRDBE]" KSTUYCK1@PRDBE.JNJ.COM Subject: [NMusers] SS indication for dataset with BID dose and AM dose different from PM dose. Date: Tue, 11 Jul 2006 17:46:43 +0200 Dear Colleagues, I have a flexible dosing BID study where the AM dose is different from PM dose. At the time PK samples are collected, we are at the steady state condition. Is there anyone familiar with the use of SS and II in this situation? If so, could you show me how SS and II would be implemented in the dataset (please use the example I put below)? In the example below we know that the AM dose is 0.5 and PM dose is 0.8 for more than 10 days (SS is reached after 5 days for this compound) ID DV AMT DATE TIME SS II 1 0 0.8 01/01/2006 20:00 1 0 0.5 01/02/2006 08:00 1 15 0 01/01/2006 08:01 Thanks in advance for the input. Kind regards, Kim
Jul 11, 2006 Kim Stuyckens SS indication for dataset with BID dose and AM dose different from PM dose.
Jul 11, 2006 William Bachman RE: SS indication for dataset with BID dose and AM dose different from PM dose.
Jul 11, 2006 Mark Sale RE: SS indication for dataset with BID dose and AM dose different from PM dose.
Jul 11, 2006 Paul Hutson RE: SS indication for dataset with BID dose and AM dose different from PM dose.