Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach, 1st Edition

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. 

This document is available in electronic format only.

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Publication Details

Chairholder: Dan Tholen, M.S.

Date of Publication: April 1, 2003

ISBN Number: 1-56238-498-8

Order Code PDF: EP06AE

Order Code Print: print not available

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.