EDP Sciences logo
Submit your paper
Search
Menu
All issues Volume 8 (2017) Int. J. Metrol. Qual. Eng., 8 (2017) 9 References
Open Access
Review
Issue
Int. J. Metrol. Qual. Eng.
Volume 8, 2017
Article Number 9
Number of page(s) 10
DOI https://doi.org/10.1051/ijmqe/2016030
Published online 08 March 2017
  1. International Conference on Harmonization (ICH), Q2A: Text on validation of analytical procedures, March (1995) [Google Scholar]
  2. International Conference on Harmonization (ICH), Q2B: Validation of analytical procedures: methodology, May (1997) [Google Scholar]
  3. H. Holcombe, ed., The fitness for purpose of analytical methods, in A laboratory guide to method validation and related topics (EURACHEM Guide, LGC, Teddington, 1998) [Google Scholar]
  4. Food and Agriculture Organization (FAO) and International Atomic Energy Agency (IAEA), Food and nutrition paper 68: Validation of analytical methods for food control (FAO/UN, Rome, 1998) [Google Scholar]
  5. K.S. Bansal, T. Layloff, E.D. Bush, M. Hamilton, E.A. Hankinson et al., Qualification of analytical instruments for use in the pharmaceutical industry: a scientific approach, AAPS PharmSciTech 5, 1–8 (2004) [Google Scholar]
  6. P. Bedson, M. Sargent, The development and application of guidance on equipment qualification of analytical instruments, Accredit. Qual. Assur. 1, 265–274 (1996) [CrossRef] [Google Scholar]
  7. O. McPolin, The validation of analytical methods for pharmaceutical analysis (Mourne Training Services, UK, 2009) [Google Scholar]
  8. FDA, Guidance for industry: analytical procedures and method validation, chemistry, manufacturing, and controls documentation (U.S. Department of Health and Human Services, 2000) [Google Scholar]
  9. U.S. FDA, Guidance for submitting samples and analytical data for methods validation (Center for Drugs and Biologics, Department of Health and Human Services, Rockville, MD, USA, 1987) [Google Scholar]
  10. U.S. Center for Drug Evaluation and Research, Reviewer guidance: validation of chromatographic methods (1994) [Google Scholar]
  11. U.S. FDA DHHS, 21 CFR Parts 210 and 211, Current good manufacturing practice of certain requirements for finished pharmaceuticals, proposed rule (1996) [Google Scholar]
  12. <1225> Validation of Compendial Methods, U.S. Pharmacopoeia 26-National Formulary 21 (United States Pharmacopeial Convention, Rockville, MD, 2003) [Google Scholar]
  13. S. Bolton, Pharmaceutical statistics practical and clinical applications (Marcel Decker, Inc., New York, NY, 2004), 5th ed., p. 558, Table IV.2 [Google Scholar]
  14. S. Bolton, Pharmaceutical statistics practical and clinical applications (Marcel Decker, Inc., New York, NY, 2004), 5th ed., p. 561, Table IV.4 [Google Scholar]
  15. B. Belafkih, S. Belouafa, M. Charrouf, A. Bennamara, A. Skalli, F. Slaoui, A. Abourriche, Anal. Chem. 15 (6), 219–224 (2015) [Google Scholar]
  16. F. Saadoune, S. Belouafa, T. Ainane, M. Charrouf, A. Bennamara, A. Abourriche, Anal. Chem. 14 (10), 404–408 (2014) [Google Scholar]
  17. S. Benhar, S. Belouafa, A. Chafik, M. Charrouf, R. Chfiri, A. Semlali, M. Maghraoui, A. Bennamara, A. Abourriche, Anal. Chem. 15 (6), 213–218 (2015) [Google Scholar]
  18. LNE C370 X18 : Guide méthodologique pour l'estimation des incertitudes en analyse chimique du laboratoire national d'essais LNE/France [Google Scholar]
  19. W. Horwitz, R. Albert, Reliability of the determinations of polychlorinated contaminants (biphenyls, dioxins, furans), J. AOAC Int. 79, 589–621 (1996) [PubMed] [Google Scholar]
  20. Rapport de Synthèse : étude de la validation AFAQ AFNOR Certification du test REBECCA + EB pour le dénombrement des Entérobactéries selon la norme NF ISO16140 [Google Scholar]
  21. The Commission of the European Communities, Commission decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation, Off. J. Eur. Comm. L221, 8–36 (2002) [Google Scholar]
  22. B. Belafkih, S. Belouafa, M. Charrouf, A. Bennamara, A. Skalli, A. Abourriche, J. Chem. Pharm. Res. 7 (2), 940–947 (2015) [Google Scholar]
  23. S. Benhar, S. Belouafa, A. Chafik, M. Charrouf, R. Chfiri, A. Semlali, M. Maghraoui, A. Bennamara, A. Abourriche, ScienceLib Editions Mersenne 6 (2014), No. 141101 [Google Scholar]
  24. Guide pour la validation des méthodes d'essai chimico-physiques et l'évaluation de l'incertitude de mesure ; Document N° 324, Edition février, rév. 02 (2013) [Google Scholar]
  25. International Organization for standardization (ISO), ISO 13752: Air Quality – Assessment of uncertainty of a measurement method under field conditions using a second method as reference (ISO, Geneva, 1998) [Google Scholar]
  26. M.L.J. Weitzel, The estimation and use of measurement uncertainty for a drug substance test procedure validated according to USP 1225, Accredit. Qual. Assur. 17 (2), 139–146 (2012) [CrossRef] [Google Scholar]
  27. R.K. Burdick, D. LeBlond, D. Sandell, H. Yang, Statistical methods for validation of procedure accuracy and precision, Pharmacopeial Forum 39 (3) (2013) [Google Scholar]
  28. P. Nethercote, J. Ermer, Quality by design for analytical methods: implications for method validation and transfer, Pharm. Technol. 36 (10), 74–79 (2013) [Google Scholar]
  29. T.A. Little, Design of experiments for analytical method development and validation, BioPharm Int. 27 (3) (2014) [Google Scholar]
  30. N.V.V.S.S. Raman, U.R. Mallu, H.R. Bapatu, Analytical quality by design approach to test method development and validation in drug substance manufacturing, J. Chem. 1–8 (2015), Article ID: 435129 [Google Scholar]

Current usage metrics show cumulative count of Article Views (full-text article views including HTML views, PDF and ePub downloads, according to the available data) and Abstracts Views on Vision4Press platform.

Data correspond to usage on the plateform after 2015. The current usage metrics is available 48-96 hours after online publication and is updated daily on week days.

Initial download of the metrics may take a while.