Bioequivalence and Bioavailability Forum

Dear Harish!,

❝ During WinNonlin data analysis, do we need to include zero values? Eg: If the concentration at 12 hours is below the limit of quantification (BLOQ), do we need to include this timepoint as 12, BLOQ or 12, 0 for WinNonlin data analysis?

Please provide more informations! Is 12 hours the last sampling time and if not, were there following concentrations above the LLOQ?

❝ If we have measured the concentration prior to dosing & found the concentration to be BLOQ, do we need to include this timepoint as 0, BLOQ or 0, 0?

Most people would set this value to zero.

❝ Does WinNonlin treat 12, BLOQ same as 12, 0?

No. If you have a text-value (like 'BQL') in your worksheet, the value is treated as 'Missing'.
Generally it's advisable to define a procedure in an SOP, which can be implemented in WinNonlin by means of the 'Status Code Transformation Wizzard' (Tools > Status Codes (i.e. BQL)...). For details see the 'WinNonlin User' Guide' p 69-74 (for v5.2.1).