Population pharmacokinetic characterization of <scp>BAY</scp> 81‐8973, a full‐length recombinant factor <scp>VIII</scp>: lessons learned ‒ importance of including samples with factor <scp>VIII</scp> levels below the quantitation limit

Abstract

It is essential to assess the importance of BLQ samples when performing population PK estimates of half-life for any FVIII product. Exclusion of BLQ data from half-life estimations based on population PK models may result in an overestimation of half-life and underestimation of time under a predetermined FVIII threshold, resulting in potential underdosing of patients.