Usefulness of capability indices in the framework of analytical methods validation

Analytica Chimica Acta

Volumn 714, Issue , 2012, Pages 47-56

  Bouabidi, A ^a,b   Ziemons, E ^a   Marini, R ^a   Hubert, C ^a   Talbi, M ^b   Bouklouze, A ^c   Bourichi, H ^c   Karbane, M El ^c   Boulanger, B ^d   Hubert, Ph ^a   Rozet, E ^a  

^a UNIVERSITY OF LIÈGE   (Belgium)

^b FACULTÉ DES SCIENCES BEN M SIK   (Morocco)

^c MOHAMMED V UNIVERSITY   (Morocco)

^d NONE

Author keywords

Capability; Drug products; Fit for purpose; Method validation; Tolerance intervals

Indexed keywords

ANALYTICAL METHOD; CAPABILITY; CAPABILITY INDICES; FIT FOR PURPOSE; METHOD VALIDATION; MONTE CARLO SIMULATION; OPTIMAL SAMPLES; PHARMACEUTICAL INDUSTRY; SAMPLE SIZES; TOLERANCE INTERVAL;

DRUG PRODUCTS;

INDUSTRIAL ENGINEERING;

ACETAZOLAMIDE; FLUCONAZOLE;

ACCURACY; ANALYTIC METHOD; ANALYTICAL PARAMETERS; ARTICLE; CONTROLLED STUDY; DRUG DETERMINATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIMIT OF QUANTITATION; MATHEMATICAL COMPUTING; MONTE CARLO METHOD; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SAMPLE SIZE; VALIDATION PROCESS;

ACETAZOLAMIDE; CHEMISTRY TECHNIQUES, ANALYTICAL; CHROMATOGRAPHY, LIQUID; COMPUTER SIMULATION; DRUG INDUSTRY; FLUCONAZOLE; MONTE CARLO METHOD; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; TABLETS; VALIDATION STUDIES AS TOPIC;

EID: 84855679901     PISSN: 00032670     EISSN: 18734324     Source Type: Journal    
DOI: 10.1016/j.aca.2011.11.019     Document Type: Article

References (27)

1. Dejaegher B., Jimidar M., De Smet M., Cockaerts P., Smeyers-Verbeke J., Vander Heyden Y. J. Pharm. Biomed. Anal. 2006, 42:155-170.
2. Kamberi M., Garcia H., Feder D.P., Rapoza R.J. Eur. J. Pharm. Sci. 2011, 42:230-237.
3. Raska C.S., Bennett T.S., Goodberlet S.A. Anal. Chem. 2010, 82:5932-5936.
4. Kotz S., Johnson N.L. J. Qual. Technol. 2002, 34:1-19.
5. Kotz S., Lovelace C. Process Capability Indices in Theory and Practice 1998, Arnold, London, UK.
6. Burgess C. Aberrant or atypical results: analytical process capability. Method Validation in Pharmaceutical Analysis. A Guide to Best Practice 2005, 362-366. Wiley-Verlag, Weinheim. J. Ermer, J.H. Miller (Eds.).
7. USP 33 NF 28 S1, U.S. Pharmacopeia, 2007. USP-NF General Chapter <1080>.
8. Ferignac P. Revue de statistique appliquée 1962, 10:13-32.
9. International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, 2005.
10. Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
11. Hubert Ph., N'guyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L., Rozet E. J. Pharm. Biomed. Anal. 2007, 45:82-96. http://hdl.handle.net/2268/6187.
12. Rozet E., Ceccato A., Hubert C., Ziemons E., Oprean R., Rudaz S., Boulanger B., Hubert Ph. J. Chromatogr. A 2007, 1158:111-125. http://hdl.handle.net/2268/3646.
13. Bouabidi A., Rozet E., Fillet M., Ziemons E., Chapuzet E., Mertens B., Klinkenberg R., Ceccato A., Talbi M., Streel B., Bouklouze A., Boulanger B., Hubert Ph. J. Chromatogr. A 2010, 1217:3180-3192. http://hdl.handle.net/2268/29471.
14. Hahn G.J., Meeker W.Q. Statistical Intervals: A Guide for Practitioners 1991, Wiley Edition, 392 p.
15. Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.-A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L. J. Pharm. Biomed. Anal. 2004, 36:579-586. http://hdl.handle.net/2268/6169.
16. Hubert Ph., N'guyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L., Rozet E. J. Pharm. Biomed. Anal. 2007, 45:70-81. http://hdl.handle.net/2268/6170.
17. Mee R.W. Technometrics 1984, 26:251.
18. Searle S.R., Casella G., McCulloch C.E. Variance Components 1992, Wiley.
19. Feinberg M., Boulanger B., Dewé W., Hubert P. Anal. Bioanal. Chem. 2004, 380:502-514. http://hdl.handle.net/2268/6186.
20. Dagnelie P. Statistique théorique et appliqué. 2. Inférence statistique à une et deux dimensions 2006, De Boeck Université, p. 737.
21. Bouabidi A., Talbi M., Bouklouze A., El Karbane M., Bourichi H., El Guezzar M., Ziemons E., Hubert Ph., Rozet E. J. Pharm. Biomed. Anal. 2011, 55:583-590. http://hdl.handle.net/2268/85024.
22. Rozet E., Hubert C., Ceccato A., Dewé W., Ziemons E., Moonen F., Michail K., Wintersteiger R., Streel B., Boulanger B., Hubert Ph. J. Chromatogr. A 2007, 1158:126-137. http://hdl.handle.net/2268/1810.
23. International Organization of Standardization (ISO) ISO/CEI 17025: General Requirements for the Competence of Testing and Calibration Laboratories 2005, ISO, Geneva, Switzerland.
24. Joint Committee for Guides in Metrology, JCGM 100:2008, Evaluation of measurement data - Guide to the expression of uncertainty in measurement (GUM), 2008 (available from the website:). http://www.bipm.org/.
25. Eurachem/CITAC Guide, Quantifying the Uncertainty in Analytical Measurement, second ed., 2000.
26. 2002/657/EC. Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC Concerning the Performance of Analytical Methods and the Interpretation of Results, Off. J. Eur. Commun. L221 (2002) 8.
27. ISO: 15189 Medical Laboratories - Particular Requirements for Quality and Competence 2007, International Organization of Standardization (ISO), ISO, Geneva, Switzerland.