Harmonization of strategies for the validation of quantitative analytical procedures
| Autor: | G. Muzard, L. Valat, Bruno Boulanger, E. Rozet, M. Lallier, N. Cohen, E. Chapuzet, N. Mercier, M. Laurentie, Walthère Dewé, Pierre-Albert Compagnon, J.-J. Nguyen-Huu, Ph. Hubert, Patrice Chiap, Max Feinberg, C. Nivet |
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| Rok vydání: | 2004 |
| Předmět: |
Management science
Chemistry media_common.quotation_subject 010401 analytical chemistry Clinical Biochemistry Pharmaceutical Science Context (language use) Harmonization 02 engineering and technology Commission 021001 nanoscience & nanotechnology 01 natural sciences 0104 chemical sciences Terminology Analytical Chemistry Quantitative analysis (finance) Drug Discovery Quality (business) Analytical procedures Tolerance interval 0210 nano-technology Reliability (statistics) Spectroscopy media_common |
| Zdroj: | Journal of Pharmaceutical and Biomedical Analysis. 36:579-586 |
| ISSN: | 0731-7085 |
| DOI: | 10.1016/j.jpba.2004.07.027 |
| Popis: | As reported in a previous paper, the main objective of the new commission of the Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP) was the harmonisation of approaches for the validation of quantitative analytical procedures. In a series of meetings, members of this Commission have first tried to review the objectives of analytical methods and the objectives of validation methods and to recommend the use of two-sided beta-expectation tolerance intervals for total error of validation samples (accuracy profile) in the acceptance/rejection of analytical method in validation phase. In the context of the harmonization, the other objectives were: (i) to propose a consensus on the norms usually recognized, while widely incorporating the ISO terminology; (ii) to recommend to validate the analytical procedure accordingly to the way it will be used in routine; (iii) 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 three latter objectives made by the Commission are summarised in the present paper which is the second part of summary report of the SFSTP commission. The SFSTP guide has been produced to help analysts to validate their analytical methods. It is the result of a consensus between professionals having expertise in analytical and/or statistical fields. The suggestions presented in this paper should therefore help the analyst to design and perform the minimum number validation experiments needed to obtain all the required information to establish and demonstrate the reliability of its analytical procedure. |
| Databáze: | OpenAIRE |
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