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