Analytical method comparison based upon statistical power calculations. 1992

D J Mazzo, and M Connolly
Department of Analytical and Physical Chemistry, Rhône-Poulenc Rorer Central Research, Fort Washington, Pennsylvania 19034.

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.

UI MeSH Term Description Entries
D002623 Chemistry Techniques, Analytical Methodologies used for the isolation, identification, detection, and quantitation of chemical substances. Analytical Chemistry Techniques,Analytical Chemistry Methods,Analytical Chemistry Method,Analytical Chemistry Technique,Chemistry Method, Analytical,Chemistry Methods, Analytical,Chemistry Technique, Analytical,Method, Analytical Chemistry,Methods, Analytical Chemistry,Technique, Analytical Chemistry,Techniques, Analytical Chemistry
D003627 Data Interpretation, Statistical Application of statistical procedures to analyze specific observed or assumed facts from a particular study. Data Analysis, Statistical,Data Interpretations, Statistical,Interpretation, Statistical Data,Statistical Data Analysis,Statistical Data Interpretation,Analyses, Statistical Data,Analysis, Statistical Data,Data Analyses, Statistical,Interpretations, Statistical Data,Statistical Data Analyses,Statistical Data Interpretations
D015203 Reproducibility of Results The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results. Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face

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