Concentration Statistics - BQL substitution [General Sta­tis­tics]

posted by Ben – 2020-07-07 16:37 (309 d 13:23 ago) – Posting: # 21655
Views: 2,208

Dear All

» 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

Well, another approach would be to fight for getting all measured values, including the ones where the lab tells us they are flagged as BLQ (yes, yes, I know they are "not reliable", whatever that means). But I have the feeling it is still better to use them than to ignore or set them to some fixed value. I had a nice discussion with Helmut about this topic. :-)
Any idea how this approach would behave? (could not see it within the article, question is also how to simulate such unreliable data... is it just data with higher variability?)

Best regards,
Ben.

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