Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

This document provides guidance for characterizing the linearity of a method during a method evaluation; for checking linearity as part of routine quality assurance; and for determining and stating a manufacturer's claim for linear range. The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement

Clinical And Laboratory Standards Institute [clsi]

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