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Multiple dose simulated data to predict Ctrough and Cmax as each cycle

Ctrough Cmax Multiple Dose Simulation

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#1 abpkpd

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Posted 14 March 2017 - 05:11 PM

I have simulated an multiple dose IV infusion PK data using a 2 compartment model (4 cycles). From this data, I want to enlist Cmax and Ctrough values for each cycle. I have used the same data to perform NCA to get partial AUCs for individual cycle but I don't see an easy way to estimate the Cmax and Ctrough for each cycle through NCA. I am wondering if Data wizard is the only option or I am missing out an easy way to do it. I think it may be a multi step process If i have to use data wizard.

Please recommend if there is a better option.

Thanks



#2 bwendt@certara.com

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Posted 14 March 2017 - 05:15 PM

WinNonlin NCA only supports one dose per analysis profile. To do multiple dose analysis using NCA, you could add a new column to your input dataset named e.g. "Dosenum" that represents which sequential dose is being analyzed (e.g. 1st dose, 5th dose, etc). Then use this new column as a Sort variable for the NCA analysis. This will create a separate NCA analysis for each dose (e.g. Cmax and Ctrough). An example procedure is as follows:
 
1. Add a new column to your simulation data, e.g. "Dosenum"
 
 
 
2. Enter values in the new column corresponding to the number of the dose, e.g. "Dose1" or "Dose2"
 
 
 
3. In the NCA model, use both Subject and Dosenum as Sort variables
 
 
 
4. Select Setup | Dosing to enter the amounts of each dose for each subject.
 
 
 
 
Bernd


#3 abpkpd

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Posted 14 March 2017 - 05:38 PM

Thank you for your prompt response. I was able to sort the data and I got Cmax and Clast (Ctrough). But to add the column to the simulated data i had to export it to excel, I think there must be an easy way to do that in Phoenix itself.

Thanks again. 



#4 Simon Davis

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Posted 15 March 2017 - 03:35 PM

If you attach your project thne perhaps we can show a more elegant way to do this, or you can try yourself, I think a descriptive stats to pick out min and max and then merging them back against the original data file with an inner join might be one way.

 

As Bernd already indicated you would have to have some sort of profile identifier in your dataset, one way might be to use an if statement on time e.g.

if(time<24,'Day 1',if(time<48,'Day 2',if(time<72,'Day 3','Day 4')))

 

 Simon







Also tagged with one or more of these keywords: Ctrough, Cmax, Multiple Dose Simulation

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