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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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
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.