Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification, robustness and matrix effect-Reference-Cited by-同舟云学术

Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification, robustness and matrix effect

Published:2014-08 Issue: Volume:1353 Page:10-27
ISSN:0021-9673
Container-title:Journal of Chromatography A
language:en
Short-container-title:Journal of Chromatography A

Author:

González Oskar,Blanco María Encarnación,Iriarte Gorka,Bartolomé Luis,Maguregui Miren Itxaso,Alonso Rosa M.

Publisher

Elsevier BV

Subject

Organic Chemistry,General Medicine,Biochemistry,Analytical Chemistry

Reference163 articles.

1. International Organisation for Standardisation, ISO/IEC17025, General requirements for the competence of testing and calibration laboratories, 2005.

2. International Organisation for Standardisation, ISO/IEC15819, Medical laboratories — Particular requirements for quality and competence, 2012.

3. U.S Department of Health and Human Services, Food and Drug Administration, Draft Guidance for Industry: Bioanalytical Method Validation, 1999.

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