“Embedded BQLs” [NCA / SHAM]

posted by mittyri – Russia, 2016-03-21 22:17 (1600 d 15:42 ago) – Posting: # 16124
Views: 3,412

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:

Activity
 Admin contact
20,982 posts in 4,374 threads, 1,460 registered users;
online 17 (0 registered, 17 guests [including 13 identified bots]).
Forum time: Saturday 15:00 CEST (Europe/Vienna)

Patients may recover in spite of drugs or because of them.    John Gaddum

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