Bioequivalence and Bioavailability Forum

Data imputation [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2020-07-02 11:15 (471 d 11:56 ago) – Posting: # 21635
Views: 2,892

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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Helmut Schütz


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Complete thread:

• Concentration Statistics - BQL substitution SaraCHenriques 2020-07-01 14:37 [General Sta­tis­tics] 
  • Concentration Statistics - BQL substitution Helmut 2020-07-01 15:27
    • Concentration Statistics - BQL substitution martin 2020-07-02 09:37
      • Data imputationHelmut 2020-07-02 11:15
      • Concentration Statistics - BQL substitution ElMaestro 2020-07-02 13:48
        • Concentration Statistics - BQL substitution martin 2020-07-02 14:52
      • Concentration Statistics - BQL substitution Ben 2020-07-07 16:37
        • BQL in BE and PK modeling Helmut 2020-07-08 10:23
        • Concentration Statistics - BQL substitution ElMaestro 2020-07-08 11:35
        • Roger again mittyri 2020-07-08 12:03