BQL rule: At time points in the lag-time between time 0 and the first quantifiable concentration, concentrations below LLOQ will be calculated as 0

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1

Hi,

I want to apply the BQL tool to manage non-numeric data.

In my SAP the rule mentioned above was defined:

“At time points in the lag-time between time zero and the first quantifiable concentration, concentrations below LLOQ will be calculated as zero.”

The BQL offers only one approach for LLOQ values before Tmax. Do you have an idea how to implement the rule defined in the SAP?

Best regards,

Robert

2

Off hand Robert, I can’t tink of an easy workaround, at least with the BQL wizard itself, but I imagine that differences in real life between;

replace BQL before Tlag with zero

and

replace BQL before Tmax with zero would be rare and you could run a cross check after NCA with using Tlag and Tmax to search the Times in Summary table and identify any that were ‘wrong’ to your SOP and then manually update them before the NCA.

I’ll have a think on it but that’s my immeditate suggestion for now.

Simon.