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Yang Liu urges parallelism data when using surrogate matrices
Summary
Yang Liu recommended adding parallelism studies to compare surrogate and authentic matrix calibration curves (even for chromatographic methods) so reviewers can assess whether surrogate calibrators and authentic samples behave equivalently.
Yang Liu argued that parallelism — a direct comparison of concentration–response between surrogate and authentic matrices — provides reviewers confidence that a surrogate matrix behaves the same as authentic matrix for quantitation. He said parallelism is commonly considered for ligand binding assays but recommended it for chromatographic methods using surrogate matrices as well.
The speaker recommended including at least one parallelism validation set in reports because reviewers do not have access to method development data and thus need explicit evidence of sameness between matrices. Missing parallelism data can cause reviewers to judge a method inadequate even if QC accuracy/precision criteria are met.
Yang Liu suggested a parametric approach where curves in surrogate and authentic matrices are compared and, where appropriate, extrapolation of the authentic curve can produce a more accurate endogenous concentration estimate for blank pooling and QC design.
