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?
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Posted 16 June 2020 - 03:23 PM
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.
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