Design and analysis of analytical method transfer studies.
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.
Schwenke
James R
JR
Biometrics and Data Management, Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, P.O. Box 368, Ridgefield, CT 06877-0368, USA. james.schwenke@boehringer-ingelheim.com
O'Connor
Dennis K
DK
D000704:Analysis of Variance; D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000379:methods* / Q000592:standards; D004345:Drug Industry; D007753:Laboratories; D015233:Models, Statistical; D015203:Reproducibility of Results; D012107:Research Design