Bioequivalence and Bioavailability Forum • BLQ values in Winnonlin

BLQ values in Winnonlin [Software]

posted by Dr. Harish L. Rao – India, 2009-09-10 09:53 (6132 d 07:48 ago) – Posting: # 4182
Views: 22,264

Dear Group Members,

During a PK study till 72 hours,

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? If so, which AUC do we need to report (AUC0-12 or AUC0-72 or both)?
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?
3. Can we totally delete all the timepoints after 12 hours in Winnonlin and use only the data till 12 hours?
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?
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"?
2. Can we round it off to zero (eg: 8.0) and use it in Winnonlin?

Thanks & regards,
Dr. Harish L. Rao

Edit: List formated. [Helmut]