Setting Acceptance Limits – Equivalence Limits for Assessing Similarity as an Example
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*Walter W. Hauck, US Pharmacopeia 

Keywords: equivalence limits

In its general chapters Design and Development of Biological Assays <1032>, Validation of Biological Assays <1033>, and Analysis of Biological Assays <1034>, the US Pharmacopeia proposes an equivalence testing approach for many applications. As with any equivalence test, the most difficult component is the setting of the equivalence limits. This talk will review the various approaches to setting these limits for the problem of assessing similarity (parallelism), with discussion of more general application.