Design and analysis of method equivalence studies

  • Borman P
  • Chatfield M
  • Damjanov I
 et al. 
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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 difference between the two data sets can be calculated along
with a ±90% confidence interval using the TOST approach. It
can then be established whether equivalence of the two methods has
been demonstrated.

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