“Embedded BQLs” [NCA / SHAM]

posted by mittyri – Russia, 2016-03-21 23:17 (2929 d 16:55 ago) – Posting: # 16124
Views: 4,205

Hi arl_stat,

It was discussed on the forum, I would recommend you to read these threads: BLQ values in Winnonlin, ANVISA's POV on "triangulation points", LLOQ/2 for BQLs not suggested.

In a nutshell:
  1. You should unambigously state in the Protocol how to deal with these situations.
  2. If you didn't mention it in the Protocol you should find your appropriate SOP.
  3. You have at least 3 options:
    1. Interpolate this value (linear or logarithmic depending on stated algo of AUC calculation),
    2. LLOQ/2 (may be not a best idea)
    3. Deal it as zero.

Kind regards,
Mittyri

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
121 visitors (0 registered, 121 guests [including 4 identified bots]).
Forum time: 16:13 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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