Concentration Statistics - BQL substitution [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2020-07-02 13:48 (146 d 07:08 ago) – Posting: # 21636
Views: 1,888

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.

Complete thread:

Activity
 Admin contact
21,210 posts in 4,426 threads, 1,481 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Wednesday 19:57 CET (Europe/Vienna)

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5