Exclusion of PK parameters where less than 3 quantifiable concentrations [NCA / SHAM]

posted by Babe_Ruth – USA, 2018-06-19 18:13 (992 d 08:18 ago) – Posting: # 18924
Views: 2,155

I read in a PK report: "Where less than 3 quantifiable concentrations, AUC is not reported." Is this because of imprecision and inaccuracy with calculations due to lack of data points?

Should this rule be extended to all PK parameters (such as Tmax/Cmax)? What's the harm or benefit for excluding Tmax/Cmax?

The way I see it, if you only have two sequential concentrations above quantifiable limit, then you can generate a Tmax, but you can't be sure of the accuracy of Tmax, especially if Cmax is barely above quantitation limit of the assay used.

Edit: Category changed; see also this post #1[Helmut]

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