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Register“Embedded BQLs” [NCA / SHAM]
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:
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:
- You should unambigously state in the Protocol how to deal with these situations.
- If you didn't mention it in the Protocol you should find your appropriate SOP.
- You have at least 3 options:
- Interpolate this value (linear or logarithmic depending on stated algo of AUC calculation),
- LLOQ/2 (may be not a best idea)
- Deal it as zero.
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- 0.00 concentration value between two measurable concentrations arl_stat 2016-03-02 10:13
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 0.00 concentration value between two measurable concentrations arl_stat 2016-03-21 12:41
- “Embedded BQLs”mittyri 2016-03-21 22:17
- “Embedded BQLs” arl_stat 2016-04-15 08:50
- “Embedded BQLs”mittyri 2016-03-21 22:17
- 0.00 concentration value between two measurable concentrations arl_stat 2016-03-21 12:41
Ing. Helmut Schütz