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Dear All,
We would like to know how to predict steady state concentration data
using WinNonlin 5.2 for a drug X following non linear kinetics when
single dose data is available.
Thanks & Regards,
Ravi Shankar Pandey
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Dear ravi,
There is an option on winNonlin 5.2 for steady state in dosing regimen
etc. set then calculate.
Thanks & regards,
Venkatesan
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Hello Ravi,
If you know your dosing interval, Css will be AUC after single dose
upon your dosing interval.
However, I am just wondering what do you mean by nonlinear kinetics
after a single dose..Did I miss some thing? Please let me know..
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The following message was posted to: PharmPK
Dear Mr. Ravi Talluri,
Thanks for replying.
Dosing interval in our case is 24 hrs. As per literature available Drug
X follows Non-Linear Kinetics and Concentration time data available with
us is after single dose administration.
Thanks & Regards,
Ravi Shankar Pandey
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Dear Ravi,
WinNonlin has option to calculate the concentration at either N th
dose or at steady state. (WinNolin > Tools> Nonparametric
superposition...then follow the instruction given in this option)
It will give you the predicted concentration at Nth dose/steady state.
WinNolin will predict the concentrations considering linear PK.
Rerun the Winloine using predicted concentration it will give you AUC,
Clss.
As you mention that your drug is following Non-linear kinetics, it
will leads to either more than dose proportional (if CLiv decrease
with increase in dose...generally saturation of CYPs) or less than
dose proportional (generally induction of CYPs) increase in exposure
following repeated administration.
Regards,
Prashant Nigade
Sai Advantium, Pune
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