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inter subject variance for general PK study

PK parameters

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#1 Renee

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Posted 12 May 2020 - 05:18 AM

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 cradhakr

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Posted 12 May 2020 - 05:48 AM

 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.

Attached Thumbnails

  • CV%.png


#3 Renee

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Posted 22 May 2020 - 01:35 AM

 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.

Thank you!



#4 Helmut Schütz

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Posted 16 June 2020 - 03:23 PM

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.


 Best regards,
Helmut

http://forum.bebac.at/





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