Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal Part IV. Examples of application

Ph Hubert (1) , J-J Nguyen-Huu (2) , B Boulanger (3) , E Chapuzet , N Cohen (4) , W Dewé (5) , Max Feinberg (6) , M Laurentie , N Mercier , G Muzard (7) , L Valat (8) , E Rozet (1)

1 Université de Liège
2 Sanofi-Aventis
3 UCB
4 Laboratoires Expanscience
5 GlaxoSmithKline
6 MET@RISK - Méthodologies d'Analyse de Risque Alimentaire
7 Merck Theramex
8 Viatris-Manufacturing

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 fourth 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. (C) 2008 Elsevier B.V. All rights reserved.

Mots clés: accuracy profile; liquid chromatography

Mots clés: total error; ELISA; masse spectrométrique

Domaines: Sciences pharmaceutiques

Ph Hubert, J-J Nguyen-Huu, B Boulanger, E Chapuzet, N Cohen, et al.. Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal Part IV. Examples of application. Journal of Pharmaceutical and Biomedical Analysis, 2008, 48 (3), pp.760-771. ⟨10.1016/j.jpba.2008.07.018⟩. ⟨hal-02665063⟩