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Dear all,
We had done analysis of an two weeks toxicology study.
Study Samples were given for 0 day, 7th day and 14 th day. All the
animals have been dosed daily once. Time points for blood collection
is from 0 to 24 hours. So while doing winnonlin should we do it with
steady state or not? How to proceed in winnonlin with such a kind of
data.
Thanks in advance,
With regards,
Veeravalli Vijaya Bhaskar
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The following message was posted to: PharmPK
Dear Vijaya,
I assume from your mail that you have data from 0-24 h on all days (0,
7 & 14). When you enter data in WinNonlin you should sort by day and
do normal NCA analysis. You need not do Steady state analysis.
If you do steady state analysis, then you have to consider cumulative
time. But in my view in tox studies, you are mainly concerned with the
dose proportionality, accumulation and gender difference, for which
steady state may not be required.
Hope this helps
Regrads
Tausif Ahmed, Ph.D.
DMPK, Sai Advantium pharma Ltd. Pune
India
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Dear Vijay
I suggest just prepare data set for day 0, day 7 and day 14 and run
NCA in winnonlin.
I think one cannot assume steady state.
Rajasekhar
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