Bioequivalence and Bioavailability Forum • BLQ values in Winnonlin

BLQ values in Winnonlin [Software]

posted by Ohlbe – France, 2009-09-11 02:18 (5338 d 17:39 ago) – Posting: # 4188
Views: 15,688

Dear Dr Harish,

❝ a. If we get BLQ values for all time points after 12 hours,

❝ 1. Do we need to include all time points after 12 hours in the "24.0", "36.0", "48.0" and "72.0" format before Winnonlin data analysis?

Including them or not will make no difference. AUC calculation will stop at the last measurable concentration for each subject.

❝ If so, which AUC do we need to report (AUC0-12 or AUC0-72 or both)?

AUC0-last (from 0 to the last concentration measured for each subject, whatever the time point).

❝ 2. In case we enter the values as BLQ in Winnonlin and define Status Code for BLQ as "Missing", does Winnonlin totally omit these time points?

BLQ is not missing: you do have a value. Not a big problem for the last sampling points, but don't replace BLQ with missing if you have a measurable concentration at a later time point.

❝ 3. Can we totally delete all the timepoints after 12 hours in Winnonlin and use only the data till 12 hours?

If all time points after 12 hours are BLQ, omitting them will make no difference.

❝ b. If BLQ values are found after 24 hours for 2 subjects and after 36 hours for 4 subjects,

❝ 1. Do we need to report AUC(0-12) or AUC(0-36) or both?

None. You have to report AUC0-last.

❝ c. In another rare case, if we have BLQ values in between (eg: 8 hrs.) and before 12 hours,

❝ 1. Can we use Status Codes and treat the timepoint as "Missing"?

BLQ is BLQ is BLQ, not missing. You do have a result.

❝ 2. Can we round it off to zero (eg: 8.0) and use it in Winnonlin?

That's even what I would expect you to do. If it is the last time point: it will not be used for AUC calculation. If there are measurable concentrations at a later time point: it will be considered as 0.

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

BLQ values in Winnonlin Dr. Harish L. Rao 2009-09-10 07:53 [Software]
- BLQ values in WinnonlinOhlbe 2009-09-11 00:18
  - BLQ values in Winnonlin > Status codes tool SDavis 2009-09-11 08:13
    - BLQ values in Winnonlin > Status codes tool Ohlbe 2009-09-11 22:19
      - Irregular profiles Helmut 2009-09-14 17:11
        
        About "PK repeats" Ohlbe 2009-09-14 22:01
        
        About "PK repeats" Helmut 2010-10-21 15:51
        
        About "PK repeats" Ohlbe 2010-10-21 16:38
        
        About "PK repeats" Helmut 2010-10-21 17:01
        
        About "PK repeats" Ohlbe 2010-10-21 17:32
        
        slowly going off-topic Helmut 2010-10-21 18:47
        
        About "PK repeats" ElMaestro 2010-10-21 16:56
        
        About "PK repeats" Helmut 2010-10-21 18:02
        
        BLQ Values in Winnonlin Dr. Harish L. Rao 2009-09-15 05:45