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Activity Number: 174 - Biomarkers and Endpoint Validation
Type: Contributed
Date/Time: Monday, July 30, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #327223
Title: Statistics Used in Assay Validation
Author(s): Kenneth Liu*

Assays measure the amount of a substance in blood samples such as antibodies. Assay measurements have variability so they need to be validated to characterize their properties.

Statisticians working with data from assays may be required to write or review these assay validation reports.

We will look at a sample assay validation report and discuss the following concepts and the statistics which are used to evaluate them: 1 Robustness 2 Precision 3 Trueness 4 Uncertainty 5Limits of quantification 6 Dilutional linearity 7 Parallelism 8 Recovery 9 Selectivity 10 Sample stability

Authors who are presenting talks have a * after their name.

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