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Yang Liu: Surrogate‑matrix bioanalysis offers sensitivity gains but demands extra validation
Summary
At a technical presentation, Yang Liu outlined how surrogate‑matrix approaches can provide analyte‑free calibrators and greater sensitivity for endogenous drugs, but cautioned they require additional validation (parallelism, authentic‑matrix QCs and matrix‑effect testing) before use in BE studies.
Yang Liu, identified in the transcript as from "d v 3 0 b o g d," said surrogate‑matrix methods can improve sensitivity and avoid interference from endogenous analyte present in authentic human plasma, but stressed these methods require expanded validation to support bioequivalence (BE) conclusions.
"Surrogate matrix approach can offer a lot of benefits, but also it require additional consideration," Yang Liu said, noting that surrogate matrices provide analyte‑free calibrators and often stronger chromatography sensitivity. The speaker recommended preparing quality control (QC) samples in authentic matrix for validation comparison and urged parallelism studies to demonstrate sameness between surrogate and authentic matrices.
Why it matters: for endogenous drugs the measured post‑dose concentration is the basis for pharmacokinetic (PK) assessment and BE decisions, so analytical choices that affect sensitivity or introduce bias can change whether two products are judged bioequivalent. Yang Liu emphasized that passing accuracy and precision criteria in QCs alone does not guarantee a surrogate approach is adequate.
The speaker recommended reviewers expect at minimum authentic‑matrix QC in validation, and in many cases both surrogate‑ and authentic‑matrix QCs and parallelism data. He also recommended using stable‑isotope internal standards and optimized extraction and chromatography to mitigate matrix differences.
Yang Liu closed by noting the surrogate‑matrix category is broad (buffers, depleted human plasma, or other species matrices) and that choosing and validating the right surrogate is critical to avoid loss of meaningful BE data.
