Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Qc Lot Selection topic
No spam. Unsubscribe anytime.
Yang Liu: Screen QC plasma lots to ensure low‑end bracketing for endogenous analytes
Summary
Using a second mock example, Yang Liu recommended screening authentic plasma lots for low endogenous background to prepare authentic low QC that bracket observed BE sample concentrations and avoid leaving many samples outside the validated range.
In a second case study (called "endogenous drug b"), Yang Liu described how pooled plasma lots with relatively high endogenous concentration (e.g., 60 ng/mL) used to prepare authentic low QC produced nominal low QC concentrations (about 75 ng/mL) that left many BE samples below the validated QC range.
The presenter said a practical remedy is to screen more authentic plasma lots and select those with lower endogenous background (the mock example selected lots averaging ~10 ng/mL), then prepare authentic low QC by spiking three times the LLOQ to produce a nominal concentration that better brackets typical pre‑dose and elimination samples.
Yang Liu said this approach gives both the applicant and reviewers more confidence that BE samples are bracketed by validation QCs and reduces the need for partial validation or ad‑hoc justifications later in review.
