Concentration Statistics - BQL substitution [General Sta­tis­tics]

posted by martin  – Austria, 2020-07-02 11:37 (950 d 06:12 ago) – Posting: # 21634
Views: 4,007

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

Complete thread:

UA Flag
Activity
 Admin contact
22,485 posts in 4,710 threads, 1,603 registered users;
21 visitors (0 registered, 21 guests [including 8 identified bots]).
Forum time: 16:50 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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