Abstract
Testing for the equivalence of results generated by different analytical methodology is a common practice in the pharmaceutical sciences. Methodology changes are implemented for both scientific and economic reasons during a scientific study. Thus, the need to demonstrate the appropriateness of considering data generated by distinct methods as part of a single information population arises. This paper describes a rapid and simple approach to the statistical design and interpretation of method comparison experiments. The approach presented is based upon a statistical power calculation technique, a knowledge of the variability associated with the methods to be compared and the criteria for equivalence (the limits within which differences become immeasurable or, for practical purposes, insignificant). Reference tables are included which show necessary sample sizes for comparison experiments for common combinations of these three variables.
Similar content being viewed by others
REFERENCES
J. O. Westgard and M. R. Hunt. Use and interpretation of common statistical tests in method-comparison studies. Clin. Chem. 19(1):49–57 (1973).
G. T. Wu, S. L. Twomey, and R. E. Thiers. Statistical evaluation of method-comparison data. Clin. Chem. 21(3):315–320 (1975).
P. J. Cornbleet and M. C. Shea. Comparison of product moment and rank correlation coefficients in the assessment of laboratory method-comparison data. Clin. Chem. 24(6):857–861 (1978).
M. Thompson. Regression methods in the comparison of accuracy. Analyst 107:1169–1180 (1982).
M. J. Bookbinder and K. J. Panosian. Using the coefficient of correlation in method-comparison studies. Clin. Chem. 33(7):1170–1176 (1987).
R. N. Carey, S. Wold, and J. D. Westgard. Principal component analysis: An alternative to “referee” methods in method comparison studies. Anal. Chem. 47(11):1824–1829 (1975).
D. M. Holland and F. F. McElroy. Analytical method comparisons by estimates of precision and lower detection limit. Environ. Sci. Technol. 20(11):1157–1161 (1986).
W. C. Griffiths, P. Camara, I. Diamond, and J. C. Pezzullo. A procedure for estimating bias between quantitative analytical methods. J. Autom. Chem. 8(3):147–150 (1986).
J. D. Haynes, J. Pauls, and R. Platt (chairman). Statistical Aspects of a Laboratory Study for Substantiation of the Validity of an Alternate Assay Procedure: The Greenbrier Procedure. Final Report of the Standing Committee on Statistics to the Pharmaceutical Manufacturer's Association (Quality Control Section), Washington, D.C., March 14, 1977.
M. J. Cardone, S. A. Willavize, and M. E. Lacy. Method validation revisited: A chemometric approach. Pharm. Res. 7(2):154–160 (1990).
J. C. Miller and J. N. Miller. Statistics for Analytical Chemis-try, 2nd ed., Ellis Horwood, Chichester, England, 1988, pp.75–77.
R. Caulcutt and R. Boddy. Statistics for Analytical Chemists, Chapman and Hall, New York, 1983.
SAS Institute Inc. SAS Language Guide for Personal Computers, Release 6.03 Edition, SAS Institute Inc., Cary, N.C., 1988.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Mazzo, D.J., Connolly, M. Analytical Method Comparison Based upon Statistical Power Calculations. Pharm Res 9, 601–606 (1992). https://doi.org/10.1023/A:1015885607013
Issue Date:
DOI: https://doi.org/10.1023/A:1015885607013