EP06
Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach
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.
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Chairholder: Dan Tholen, M.S.
Date of Publication: April 1, 2003
Order Code PDF: EP06AE
ISBN Number: 1-56238-498-8
Order Code Print: EP06A
ISBN Number: 1-56238-498-8
Edition: First
Pages: 47
EP06 Additional Details
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement.