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Analyzing highly variable potency data using a linear mixed-effects measurement error model |
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| Authors: | |
| Institution: | 1.Merck Research Laboratories,West Point |
| Abstract: | A house standard lot is tested along with experimental samples in a variable TCID50 assay in order to monitor and control assay performance. Instead of being simply a control, it is proposed to use this lot as a calibration standard to reduce the systematic variability in the assay caused by acknowledged sources of variability such as the age of the cells used in the assay and interlaboratory differences. Because of this new proposal, the consistency of the relationship between the test sample and the house standard is assessed within the acceptance range of the house standard. A linear mixed-effects measurement error model is proposed for the data. The slope curve is then used to assess the dynamic relationship between the sample and the house standard within the house standard range. It is shown with these analyses that the sample and the house standard have uniformly good agreement within the house standard range. |
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