arl_stat
☆    

India,
2016-03-02 10:13

Posting: # 16042
Views: 4,220
 

 0.00 concentration value between two measurable concentrations [NCA / SHAM]

Hello Forum Members,

In a data, we received 0.00 concentration value between two measurable concentrations. How to handle this?
Should we exclude the 0.00 concentration value for calculation of AUC?
Also what is the regulatory requirements.

For eg:
Subj  Conc
1     0.00
1     0.00
1     0.00
1     0.00
1     0.36
1     0.00
1     0.00
1     0.00
1     0.71
1    25.79
1    99.09
1    85.30
1    66.10
1    35.62
1    12.61
1     0.00
1     0.00
1     4.69
1     3.83
1     3.12
1     2.21
1     1.81
1     1.11
1     0.73
1     0.00
1     0.25
1     0.00
1     0.00
1     0.00


Thanks.


Edit: Category changed. Can you please post sampling times instead of the subject number? [Helmut]
arl_stat
☆    

India,
2016-03-21 12:41

@ arl_stat
Posting: # 16123
Views: 3,058
 

 0.00 concentration value between two measurable concentrations

» Can you please post sampling times instead of the subject number?

Hello,

Sorry for delay.
The time points are:
0.0, 2.0, 4.0, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.0, 14.5, 15, 16, 17, 18, 20, 24, 30, 36, 48, 60, 72.

Thanks.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post!
You gave 34 time points and 29 concentrations. Were the last five “zero” as well? What was the LLOQ? [Helmut]
mittyri
★★  

Russia,
2016-03-21 22:17

@ arl_stat
Posting: # 16124
Views: 3,103
 

 “Embedded BQLs”

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
arl_stat
☆    

India,
2016-04-15 08:50
(edited by Ohlbe on 2016-04-15 09:46)

@ mittyri
Posting: # 16206
Views: 2,379
 

 “Embedded BQLs”

Thank you!!!


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
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