4 replies to this topic

[vipul.kumar]

Hi All,

I am wondering how can we get CLss/F parameter reported in NCA parameter output.

There is a multiple dose BID PO data and on Day5, I would like to get CLss/F reported in PK parameters. 

 

Thanks much in advance for your help !

 

Vipul

 

[Simon Davis]

Simply set the Tau value (dosing interval) to 12 in NCA's dosing tab and you will have the analysis performed as per steady state.

 

Be sure to set your dose time correctly depending on how you have structured your data e.g. if Day 5, first dose and time is stated as continous time from first dose then I imagine it would be 96h.

 

 Simon.

[vipul.kumar]

Simply set the Tau value (dosing interval) to 12 in NCA's dosing tab and you will have the analysis performed as per steady state.

 

Be sure to set your dose time correctly depending on how you have structured your data e.g. if Day 5, first dose and time is stated as continous time from first dose then I imagine it would be 96h.

 

 Simon.

Thanks Simon for your quick reply. The 2nd dose is given 10 h after first dose actually and hence to my earlier question, I was thinking of treating Day 5, 2nd dose data as Steady state (running its NCA separately). So is there a way one can indicate during NCA that this is steady state data and NCA in turn will return CLss/F ?

 

Thanks !!

[Simon Davis]

Vipul, are you saying that you don't have a regular interval between doses, e.g, it is 0,10,24,34,48 etc.?

 

It is unfortunate that people design a study like this and then want to perform NCA since they should be aware that NCA formulas for clearance etc. at SS, do not support irregular dosing intervals.

 

  You could use 12h as your tau but it's an approximation, in future I would request 12h intervals are scheduled.

 

  Regarding you other questions it's a bit unclear, why don't you try it in the project and then if you don't get the output you expect then post the project then for comments.

 

  Simon.

 Simon.

[vipul.kumar]

Vipul, are you saying that you don't have a regular interval between doses, e.g, it is 0,10,24,34,48 etc.?

 

It is unfortunate that people design a study like this and then want to perform NCA since they should be aware that NCA formulas for clearance etc. at SS, do not support irregular dosing intervals.

 

  You could use 12h as your tau but it's an approximation, in future I would request 12h intervals are scheduled.

 

  Regarding you other questions it's a bit unclear, why don't you try it in the project and then if you don't get the output you expect then post the project then for comments.

 

  Simon.

 Simon.

Thanks Simon for additional information and I understand your side.

My second comment is somewhat irrelevant now and have a come around by which I am applying D/AUCtau-ss as a mean to calculate Clss/F.

Thanks again for all your help on this topic !

 

Vipul