## Data imputation [General Sta­tis­tics]

Hi Martin,

» […] adequate handling would require some modeling which seems to be in contradiction to regulatory thinking as NCA is clearly favored in BA/BE studies.

Yep. The EMA’s BE-GL states:

Non-compartmental methods should be used for determination of pharmacokinetic parameters in bioequivalence studies. The use of compartmental methods for the estimation of parameters is not acceptable.

» However, I would like to bring a recent paper on this topic to your attention: […]

Why am I not surprised that Thomas recommends kernel density imputation?
However, PK modeling is not applied. $$\small{\widehat{AUC}}$$ is still obtained by NCA, right?

Dif-tor heh smusma 🖖
Helmut Schütz

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