Reduced-method robustness testing of analytical methods driven by a risk-based approach

Pharmaceutical Technology

Volumn 34, Issue 4, 2010, Pages 72-86

  Borman, Phil ^a   Chatfield, Marion ^b   Jackson, Patrick ^c   Laures, Alice ^c   Okafo, George ^d  

^a Analytical Sciences/Chemical Development   (United Kingdom)

^b Statistical Sciences ^*  (United Kingdom)

^c Analytical Chemist in Analytical Sciences/chemical Development   (United Kingdom)

^d GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL METHOD; ASSESSING METHOD; ASSESSMENT TOOL; DEVELOPMENT PROCESS; FRACTIONAL FACTORIAL DESIGNS; POTENTIAL RESOURCES; RISK-BASED; RISK-BASED APPROACH; ROBUSTNESS TESTING;

ANALYTIC METHOD; ANALYTICAL PARAMETERS; COST CONTROL; DRUG QUALITY; GAS CHROMATOGRAPHY; REVIEW; RISK ASSESSMENT; RISK REDUCTION; SCORING SYSTEM; VALIDATION PROCESS;

EID: 77952113768     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (22)

1. B.A. Olsen, Pharm. Technol. 29 (3), suppl. s14-s25 (2005).
2. T.K. Natishan, Amer. Pharm. Outs. 7 (3), 28-35 (2006).
3. L. Mockus and P. Basu, AI ChE Annual Conference Proceedings, 1741-1745 (2004).
4. P. Borman et al., Pharm. Technol. 31 (12), 142-152 (2007).
5. M. Schweitzer et al., Pharm. Technol. 34 (2), 52-59 (2010).
6. L.D. Torbeck, Pharm. Technol. 20 (3), 168-172 (1996).
7. G. Shabir, Pharm. Technol. Eur. 13 (12), 72-76 (2001).
8. P.G. Muijselaar, Sep. Sci. and Technol. 9, 145-169 (2008).
9. C. Beaver, Drug Discovery World, 9 (4), 21-27 (2008).
10. R. Bergman et al., Chemometric and Intelligent Lab Systems, 44 (1-2), 271-286 (1998).
11. C. Ye et al., Jrnl. of Pharm. and Biomed. Anal. 50 (3) 426-431 (2009).
12. V.R. Meyer, J. Chrom. Sci. 41 (8), 439-443 (2003).
13. D.H. Stamatis, Failure Mode and Effect Analysis: FMEA from Theory to Execution (ASQ Quality Press, WI, USA, 2003).
14. R.L. Plackett and J.P. Burman, Biometrika 33 (1946) p. 305.
15. V. Heyden, M.S. Khots, and D.L. Massart, Anal. Chim. Acta. 276 (1), 189-195 (1993).
16. R. Ragonese, M. Mulholland and J. Kaiman, J. Chrom. A. 870 (1-2), 45-51 (2000).
17. A.M-F. Laures et al., Rapid Commun. Mass Spectrom. 21, 529-535 (2007).
18. E. Champarnaud et al., Rapid Commun. Mass Spectrom. 23, 181-193 (2009).
19. D.R. Holcomb, D.C. Montgomery and W.M. Carlyle, Quality Engin. 19 (1), 17-27 (2007).
20. D.K.J. Lin, "Supersaturated Designs," in Encyclopedia of Statistics in Quality and Reliability, Eds. F. Ruggeri, R. Kenett and F.W. Faltin (Wiley, 2007).
21. Y.V. Heyden et al., Anal. Chem., 72 (13), 2869-2874 (2000).
22. B. Dejaegher and Y.V. Heyden, Anal. Bioanal. Chem. 390,1227-1240 (2008).