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Abstract:
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Method Transfer is a part of pharmaceutical development in which an analytical procedure in one laboratory is adopted by one/more recipient laboratories. To assure an efficient and sustainable transfer of analytical procedures, a practically relevant and scientifically sound evaluation with corresponding equivalence margin is crucial. The success criterion is not statistical significance, but rather analytical relevance. Statistical equivalence testing is a statistical tool for method transfer which includes both, a practically relevant acceptance limit and a direct control of the statistical risks. The intent of equivalence testing is to demonstrate that the laboratory performances in the analytical procedure of a receiving lab is within an acceptable range of the transfer lab. Assigning acceptance criteria is the act of deciding what may be an acceptable and practical difference, which is rather challenging. This paper reviews the use of historical data and the application of statistical tools in the determination of equivalence margin, discusses some important issues related to appropriate testing designs, and point out some limitations.
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