Concentration Statistics - BQL substitution [General Sta­tis­tics]

posted by martin  – Austria, 2020-07-02 09:37 (292 d 19:14 ago) – Posting: # 21634
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Dear Helmut and Sara,

In statistical language - values <LLOQ are informatively censored and ignoring this fact can lead to biased results.

Of course, adequate handling would require some modeling which seems to be in contradiction to regulatory thinking as NCA is clearly favored in BA/BE studies. However, I would like to bring a recent paper on this topic to your attention: Barnett H, Geys H, Jacobs T, Jaki T (2020). Methods for Non-Compartmental Pharmacokinetic Analysis with Observations below the Limit of Quantification. Statistics in Biopharmaceutical Research, 1-23

best regards & hope this helps

Martin

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