Data imputation [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2020-07-02 13:15 (1391 d 16:10 ago) – Posting: # 21635
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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?

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