ABSTRACT
Statistical comparisons are helpful in objectively assessing comparability between a historical (prechange) and new (postchange) manufacturing process, site, formulation, or delivery device. When the objective of the comparison is to demonstrate that the stability profiles (i.e., slopes of a performance attribute over time) of two processes are highly similar, an equivalence approach is recommended. The authors present an approach for testing statistical equivalence of two stability profiles. The authors discuss concepts, selection of an equivalence acceptance criterion, sampling design considerations, and data analysis.
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