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Proceedings Paper

NIR method validation: critical performance parameters
Author(s): James K. Drennen
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Paper Abstract

Numerous regulatory documents and a wide variety of books (1-4), papers and technical standards provide guidelines for method validation. Regardless of the numerous sources providing general direction to the method developer, “validation” is an extremely complex regulatory issue that is not easily defined. Proving the specificity, linearity and range of NIR methods provides unique challenges relative to more traditional analytical techniques. Various approaches for proving the validity of these performance parameters exist.

Paper Details

Date Published: 21 June 2002
PDF: 6 pages
Proc. SPIE 4626, Biomedical Nanotechnology Architectures and Applications, (21 June 2002); doi: 10.1117/12.491167
Show Author Affiliations
James K. Drennen, Duquesne Univ. (United States)

Published in SPIE Proceedings Vol. 4626:
Biomedical Nanotechnology Architectures and Applications
Raymond P. Mariella; Michelle Palmer; Darryl J. Bornhop; Darryl J. Bornhop; Ramesh Raghavachari; Shuming Nie; Ramesh Raghavachari; Catherine J. Murphy; David A. Dunn; David A. Dunn; Raymond P. Mariella; Catherine J. Murphy; Dan V. Nicolau; Shuming Nie; Michelle Palmer; Ramesh Raghavachari, Editor(s)

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