Bioanalysis

Jaap Wieling, QPS Senior Vice-President, Bioanalysis & Technology R&D, Publishes on Equivalence Testing for Method Transfer

With greater globalization of Bioanalysis, the need for method transfer, either between labs within a single company, or from, say, a pharma/biotech lab to a CRO, is becoming more and more common. To date, however, existing guidelines for how to ensure successful transfers - often key in advancing drug candidates through development - are not particularly helpful. In this article, QPS' Jaap Wieling discusses various aspects of this problem and offers common-sense perspective and solutions. Examples of ideas set forth include: the importance of robustness in bioanalytical methods selected, such that they allow for small deviations from the sender lab's method while keeping the fundamentals intact; the importance of testing for data equivalence by analyzing similar samples in both labs and comparing the results; and a proposed standard method transfer procedure that the bioanalytical community could adopt, including scope, terminology, experimental design, evaluation process and planning.

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