Concentration Statistics - BQL substitution [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2020-07-02 15:48 (2181 d 14:40 ago) – Posting: # 21636
Views: 10,541

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.
—
Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
101 visitors (0 registered, 101 guests [including 14 identified bots]).
Forum time: 06:29 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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