Critical analysis of several analytical method validation strategies in the framework of the fit for purpose concept-Reference-Cited by-同舟云学术

Critical analysis of several analytical method validation strategies in the framework of the fit for purpose concept

Published:2010-05 Issue:19 Volume:1217 Page:3180-3192
ISSN:0021-9673
Container-title:Journal of Chromatography A
language:en
Short-container-title:Journal of Chromatography A

Author:

Bouabidi A.,Rozet E.,Fillet M.,Ziemons E.,Chapuzet E.,Mertens B.,Klinkenberg R.,Ceccato A.,Talbi M.,Streel B.,Bouklouze A.,Boulanger B.,Hubert Ph.

Funder

Fonds De La Recherche Scientifique - FNRS

Publisher

Elsevier BV

Subject

Organic Chemistry,General Medicine,Biochemistry,Analytical Chemistry

Reference29 articles.

1. International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology,2005

2. ISO 5725 parts 1–6, Accuracy (Trueness and Precision) of Measurement Methods and Results,1994

3. Guidance for Industry: Bioanalytical Method Validation,2001

4. The Fitness for Purpose of Analytical Methods,1998

5. ISO/CEI 17025: General Requirements for the Competence of Testing and calibration Laboratories,2005

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