NIR method validation: critical performance parameters

James K. Drennen III

doi:10.1117/12.491167

21 June 2002 NIR method validation: critical performance parameters

James K. Drennen III

Proceedings Volume 4626, Biomedical Nanotechnology Architectures and Applications; (2002) https://doi.org/10.1117/12.491167
Event: International Symposium on Biomedical Optics, 2002, San Jose, CA, United States

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.

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James K. Drennen III "NIR method validation: critical performance parameters", Proc. SPIE 4626, Biomedical Nanotechnology Architectures and Applications, (21 June 2002); https://doi.org/10.1117/12.491167

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