Concentration Statistics - BQL substitution [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2020-07-02 13:48 (120 d 02:10 ago) – Posting: # 21636
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Hi Martin,

» 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

Thanks for the reference.
I'd love to see a work where someone not only debates BLQ's but also where someone tries to discuss what the various options imply for the residual variability and thus confidence interval in BE trials; the same for missing values. I have a feeling it might not be a big deal, but I dare not say at this point what "big deal" is quantitatively.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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