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Journal of Biomolecular Screening
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Article

The Minimum Significant Ratio: A Statistical Parameter to Characterize the Reproducibility of Potency Estimates from Concentration-Response Assays and Estimation by Replicate-Experiment Studies

Brian J. Eastwood1*, Mark W. Farmen1, Philip W. Iversen1, Trelia J. Craft2, Jeffrey K. Smallwood3, Kim E. Garbison3, Neil W. Delapp4, Gerald F. Smith2

1 Statistics and Information Sciences, Eli Lilly and Company, Indianapolis, Indiana.
2 Cardiovascular Research, Eli Lilly and Company, Indianapolis, Indiana.; Current affiliation: Retired from Eli Lilly and Company.
3 Lead Optimization Biology, Eli Lilly and Company, Indianapolis, Indiana.
4 Lead Optimization Biology, Eli Lilly and Company, Indianapolis, Indiana.; Current affiliation: Retired from Eli Lilly and Company.

* To whom correspondence should be addressed. E-mail: bje{at}lilly.com.


  Abstract

The authors show by illustration that procedures used to validate the reliability of single-concentration high-throughput screens such as the signal window and Z' factor do not ensure sufficient reliability in potency estimates from concentration response assays. They develop the minimum significant ratio as a statistical parameter to characterize the fold change between 2 compounds run in the same experiment that can be considered a real difference and use this parameter to characterize the reliability of the assay. They adapt methods described by Bland and Altman to develop a simple set of 2 experiments to estimate the minimum significant ratio and show that this protocol can identify assays that lack reproducibility. The methods are then extended to validate the equivalency of the same assay run by multiple laboratories.

Key Words: minimum significant ratio, replicate-experiment studies, potency reproducibility, statistical methods

First published on February 20, 2006, doi:10.1177/1087057105285611

Journal of Biomolecular Screening 2006;11:253.

A more recent version of this article appeared on April 1, 2006

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