The full text of the paper entitled: Validation des procédures analytiques

quantitatives: harmonisation des démarches. Partie III. Exemples

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http://hdl.handle.net/2268/153969.

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A harmonized approach for the validation of analytical methods based on accuracy profile was
introduced by a SFSTP commission on the validation of analytical procedure. This third and last
document aims at illustrating this methodology and the statistics used. Therefore the validation of
real case methods are proposed such as methods for the quality control of drugs, for the
quantitation of impurities in drug substances, for bioanalysis or for the determination of nutriments.
Furthermore, different types of analytical methods are used in order to demonstrate the applicability
of the proposed approach to a wide range of methods such as liquid chromatography
(LC-UV, LC-MS), spectrophotometry or ELISA..