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Yang Liu describes matrix effects that can suppress internal standard response to >95% in BE samples
Summary
Yang Liu presented validation data examples showing internal standard (IS) response suppression rising from ~50% in validation QCs to over 95% in real BE samples, warning that severe suppression can make IS out of range and raise reviewer concerns about data accuracy.
Yang Liu reviewed matrix‑effect assessment and presented an example where the internal standard (IS) response differed markedly between surrogate (BSA buffer) and authentic human serum, with signal suppression in real subject samples rising to more than 95% in one case. The speaker said such suppression can cause many samples to have IS responses out of range and prompt reviewer questions about the accuracy of reported concentrations.
The presenter recommended mitigations: optimize sample extraction to reduce matrix differences, adjust chromatography to separate target peaks from interfering peaks, and use stable‑isotope internal standards where possible. He also noted that relying solely on QC accuracy/precision does not capture all dimensions of matrix effect risk.
Yang Liu urged labs to investigate by using pre‑dose subject samples as part of QC or targeted studies to demonstrate accuracy, and to implement best‑effort mitigations before submitting results relying on surrogate matrices.
