Design and analysis of method equivalence studies

Analytical Chemistry
Phil J BormanPatrick Jackson

Abstract

Method equivalence assessments should be considered when analytical methods are either modified or substituted. The TOST (two one sided tests) approach provides a sounder data driven method for testing equivalence than a simple comparative intermediate precision study which is typically performed as part of method validation. Prior to designing an equivalency study, an acceptance criterion (an acceptable bias between original and modified/changed method) must be chosen. The choice of acceptance criteria requires the identification of the smallest mean difference or bias between methods that is practically important. Equivalence testing in this manner is used to prove that the new method can generate data which continues to support previously established specifications. Once the acceptance criterion is decided, other aspects of the study can be designed following a set of design principles. When the design and acceptance criteria have been established, the collection of the data can commence. Demonstration of equivalence should not start until the validity of the observations has been confirmed such as assessment for outliers, normality, and comparison of variances. Once the suitability of the data is confirmed, the mean differe...Continue Reading

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Citations

Feb 1, 2011·Journal of Pharmaceutical Sciences·Frederick G Vogt, Alireza S Kord
Apr 2, 2013·Journal of Electromyography and Kinesiology : Official Journal of the International Society of Electrophysiological Kinesiology·Andreas KramerRamona Ritzmann
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Jan 10, 2019·Analytical Chemistry·Patrick JacksonTim Schofield
Jul 29, 2017·Analytical Chemistry·Daniel J Wilson, Charles R Mace

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