Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal

Autor:	N. Cohen, M. Laurentie, L. Valat, Walthère Dewé, Pierre-Albert Compagnon, J.-J. Nguyen-Huu, N. Mercier, E. Chapuzet, Eric Rozet, Philippe Hubert, Max Feinberg, G. Muzard, Bruno Boulanger
Rok vydání:	2008
Předmět:	Bioanalysis Chromatography Chemistry Clinical Biochemistry Pharmaceutical Science Chromatography liquid Harmonization Elisa assay computer.software_genre Total error Analytical Chemistry Drug Discovery Analytical procedures Data mining computer Reference standards Spectroscopy
Zdroj:	Journal of Pharmaceutical and Biomedical Analysis. 48:760-771
ISSN:	0731-7085
DOI:	10.1016/j.jpba.2008.07.018
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::b0b076ad1a669fc462634c88bf9b0a65 https://doi.org/10.1016/j.jpba.2008.07.018 Zobrazit plný text záznamu Full Text from ScienceDirect