Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition

This document addresses the design of measurement procedure comparison experiments using patient samples and subsequent data analysis techniques used to determine the bias between two in vitro diagnostic measurement procedures. 

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Publication Details

Chairholder: Jeffrey R. Budd, PhD

Date of Publication: August 30, 2013

ISBN Number: 1-56238-887-8

Order Code PDF: EP09A3E

Order Code Print: EP09A3

Edition: Third

Pages: 98

EP09 Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.