inter subject variance for general PK study

Phoenix Certara Forums Phoenix WNL basics
1

Hi,

Can someone tell me how to calculate Inter subject CV for PK parameters (e.g. AUC, Cmax) in general PK studies instead of BE studies?

Thanks,

Renee

2

Hi Renee,

You could send the data (Final Parameter Pivoted) to Descriptive Stats to calculate CV on the pk parameter.

Please see the attached image.

CV%.png
CV%.png1200×495 342 KB

3

Thank you!

4

Hi Renee,

sorry for the late response.

What do mean by “general PK studies instead of BE studies”? Administer only one drug/formulation? If yes, you can’t estimate the inter-subject variance in such a case (you are not the first one falling into this trap). The fact that you have only one observation does not mean that the intra-subject variance disappears. What you get in such a case (and BTW, in parallel designs as well) is the total or pooled variance. To separate the components you would need a crossover.