Bioanalytical method validation: How much should we do and how should we document?

Author:

Hopfgartner GérardORCID

Publisher

Springer Science and Business Media LLC

Subject

Biochemistry,Analytical Chemistry

Reference7 articles.

1. Green JM. Peer reviewed: a practical guide to analytical method validation. Anal Chem. 1996;68(9):305A–9A.

2. Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (2002/657/EC). Off J Eur Communities. 2002;L221:8–36.

3. FDA. Bioanalytical Method Validation Guidance for Industry. 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry

4. Eurachem Guide: The fitness for purpose of analytical methods – a laboratory guide to method validation and related topics. 2014https://www.eurachem.org/images/stories/Guides/pdf/MV_guide_2nd_ed_EN.pdf

5. https://www.ema.europa.eu

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