Design and Analysis of Analytical Method Transfer Studies

Abstract

A method transfer study is designed to successfully transfer technology from an origination laboratory to a destination laboratory. Following quality by design principles, a method transfer study is part of an analytical process to confirm the repeatability and ruggedness of the technology to be transferred. The primary objective of the study and statistical analysis is to demonstrate equivalence between laboratory mean responses. Additional information demonstrating the consistency of analysts within laboratories and the proficiency of each laboratory and analyst to reproduce the expected result can be obtained. Three representative study designs are discussed and an example is presented.

Key Words:

• Analytical validation
• Analytical variability
• Equivalence testing
• Quality by design

ACKNOWLEDGMENTS

The authors thank Walt Stroup of the University of Nebraska-Lincoln for assistance in the use of the MXED procedure of SAS® for analyzing method transfer data. The authors thank Reggie Saraceno and Terry Tougas for their comments and insight in reviewing this article and as members of the Boehringer Ingelheim Pharmaceuticals, Inc., discussion group on method transfer designs, of which the authors are also members. The authors also thank Toby Tamblyn of Boehringer Ingelheim Pharmaceuticals, Inc., for providing practical advice in developing a philosophy for defining equivalence deltas for method transfer studies.

Notes

Target = 250 mg assay.

Equivalence delta = 15 mg.

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