Assay Validation: Ruggedness and Robustness with Designed Experiments

Pharmaceutical Technology

Volumn 20, Issue 3, 1996, Pages 168-172

  Torbeck, Lynn D ^a  

^a Torbeck Associates   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0005036122     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (14)

1. "Validation of Compendial Methods," USP 23, section (1225) (United States Pharmacopeial Convention, Rockville, MD, 1994), pp. 1982-1984.
2. International Conference on Harmonisation, "Guideline on Validation of Analytical Procedures: Definitions and Terminology; Availability." (Federal Register, 1 March 1995).
3. International Conference on Harmonisation, "Extension of the ICH Test: Validation of Analytical Procedures," draft number 7, 28 July 1995.
4. J.F. Box, R.A. Fisher: The Life of a Scientist (John Wiley & Sons, New York, 1978).
5. ASTM, Standard Guide for Conducting Ruggedness Tests, E1169 (American Society for Testing and Materials, Philadelphia, 1989).
6. R.C. Paule, "Ruggedness Tests and Interlaboratory Studies," ASTM Standardization News, May 1988.
7. R.C. Paule et al., "Ruggedness Testing, Part I: Ignoring Interactions," J. Res. Natl. Bur. Stand. 91-1, 3-8 (1986).
8. R.C. Paule et al., "Ruggedness Testing, Part II: Recognizing Interactions," J. Res. Natl. Bur. Stand. 91-1, 9-15 (1986).
9. G. Wernimont, "Ruggedness Evaluation of Test Procedures," ASTM Standardization News 5 (3), 13-16 (1977).
10. G. Wernimont, "Evaluation of the Ruggedness of an Analytical Process," in Use of Statistics to Develop and Evaluate Analytical Methods, W. Spendley, Ed. (AOAC, Arlington, VA, 1985), pp. 78-82.
11. W.J. Youden and E.H. Steiner, "Ruggedness Test for Procedures," in Statistical Manual of the Association of Official Analytical Chemists (AOAC, Arlington, VA, 1975), pp. 33-36.
12. G. Kateman and L. Buydens, "The Ruggedness Test," in Quality Control in Analytical Chemistry (John Wiley & Sons, New York, 2d ed., 1993), pp. 118-125.
13. E.S. Pearson and H.O. Hartley, Biometrika Tables for Statisticians (Biometrika Trust, University College, London, 1976), pp. 29-32, 205-210.
14. G.E. Box, W.G. Hunter, and J.S. Hunter, Statistics for Experimenters (John Wiley, New York, 1978), p. 329.