“Embedded BQLs” [NCA / SHAM]

posted by mittyri – Russia, 2016-03-21 22:17  – Posting: # 16124
Views: 3,138

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

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