Concentration Statistics - BQL substitution [General Sta­tis­tics]

posted by martin  – Austria, 2020-07-02 09:37 (206 d 21:50 ago) – Posting: # 21634
Views: 2,174

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:

Activity
 Admin contact
21,310 posts in 4,445 threads, 1,489 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Monday 06:28 CET (Europe/Vienna)

Science may set limits to knowledge,
but should not set limits to imagination.    Bertrand Russell

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