Les laboratoires accrédités saisis par l'incertitude

Conference (2006)

Harmonisation des strategies de validation et estimation de l'incertitude associee dans le cadre de l'accreditation des laboratoires d'essais

in Acta Clinica Belgica. Supplementum (2006), S1(1), 53-55

In order to achieve the harmonization of validation strategies, the interpretation of several validation criteria is proposed. Furthermore, a simple and visual decision tool to assess the validity of an ... [more ▼]

In order to achieve the harmonization of validation strategies, the interpretation of several validation criteria is proposed. Furthermore, a simple and visual decision tool to assess the validity of an analytical procedure is described: the accuracy profile based on the estimation of the total error of the measurements. This profile build with beta-expectation tolerance intervals can also compute with efficiency the uncertainty related to the results of a laboratory, which is an essential parameter for the accreditation of laboratories under ISO 17025. [less ▲]

Validation des procédures analytiques quantitatives, Harmonisation des démarches

in STP Pharma Pratiques (2003), 13(3), 101-138

Statistical analysis of validation method revisited : the need to use the total error. Proceeding 9th international congress of the european association for Veterinary Pharmacology and Toxicology

in Journal of Veterinary Pharmacology & Therapeutics (2003), 26

New strategy for the validation of chromatographic bioanalytical methods

in STP Pharma Pratiques (2000), 10(1), 21-38

The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington Conference to the laboratory

in Analytica Chimica Acta (1999), 391(2), 135-148

On the basis of the guidelines given in the Washington Conference report and the ICH (International Conference of Harmonisation) recommendations some suggestions about experimental design and data ... [more ▼]

On the basis of the guidelines given in the Washington Conference report and the ICH (International Conference of Harmonisation) recommendations some suggestions about experimental design and data evaluation are proposed by an SFSTP Commission dedicated to the validation of chromatographic methods in bioanalysis. In a series of meetings, members of this Commission have tried to elaborate a rational, practical and statistically reliable strategy to assure the quality of the analytical results generated. This strategy has been formalised in a guide and the main suggestions made by the Commission are summarised in the present paper. The SFSTP guide has been produced to help analysts from the pharmaceutical industry to validate their bioanalytical methods, It is the result of a consensus between professionals having expertise in bioanalytical and/or statistical fields. The suggestions presented in this paper should therefore help the analyst to design and perform the minimum number of validation experiments needed to obtain all the required information to establish and demonstrate the reliability of its analytical procedure. The SFSTP guide suggests a validation strategy in two steps: a pre-validation and the validation itself. An experimental design is described for each of these steps and the main aspects discussed in the paper are related to the selection of the most appropriate calibration model to fit experimental data and the most suitable way to determine the limit(s) of quantitation and subsequently the calibration range as well as the optimum number of experiments to be performed in the validation phase. (C) 1999 Elsevier Science B.V. All rights reserved. [less ▲]

Méthodes chromatographiques de dosage dans les milieux biologiques : Stratégie de validation

Conference (1997)

SFSTP guide on validation of bioanalytical methods : a proposal

Conference (1996)