Large-Scale Retrospective Evaluation of Regulated LC-MS Bioanalysis Projects Using Different Total Error Approaches

PRESENTED TO: BioPharma Services Inc.
PRESENTED BY: A.Tana, T. Saffajb, A. Musukuc, K. Awaiyea, B. Ihssaned, F. Jhilalb, S. Alaoui Sosseb, and F. Trabelsia

PURPOSE

Large-Scale Retrospective Evaluation of Regulated LC-MS Bioanalysis Projects Using Different Total Error Approaches – Currently, the precision and trueness of a bioanalytical assay in regulated LC-MS bioanalysis are usually evaluated separately using %CV and %bias (or %nominal), e.g. within 15 and ±15, respectively. Despite its wide use, this approach has long been criticized for its inability to balance lab customer risks adequately. To remedy this, several different approaches based on total error concept (precision and trueness combined) have been proposed. However, disagreements exist regarding their respective effectiveness/usefulness. Therefore, it is very much desirable to perform a large-scale retrospective evaluation of different regulated LC-MS bioanalysis projects to find out: a) how serious the aforementioned risks might be in reality; and b) how much difference different total error approaches would make.

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Currently, the precision and trueness of a bioanalytical assay in regulated LC-MS bioanalysis are usually evaluated separately using %CV and %bias (or %nominal), e.g. within 15 and ±15, respectively. Despite its wide use, this approach has long been criticized for its inability to balance lab-customer risks adequately. To remedy this, several different approaches based on total error concept (precision and trueness combined) have been proposed. However, disagreements exist regarding their respective effectiveness/usefulness. Therefore, it is very much desirable to perform a large-scale retrospective evaluation of different regulated LC-MS bioanalysis projects to find out: a) how serious the aforementioned risks might be in reality; and b) how much difference different total error approaches would make.

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