Related Experiment Video
Updated: Jul 1, 2026

Untargeted Metabolomics from Biological Sources Using Ultraperformance Liquid Chromatography-High Resolution Mass Spectrometry (UPLC-HRMS)
Published on: May 20, 2013
Design and analysis of analytical method transfer studies
James R Schwenke1, Dennis K O'Connor
1Biometrics and Data Management, Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, P.O. Box 368, Ridgefield, CT 06877-0368, USA. james.schwenke@boehringer-ingelheim.com
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.
More Related Videos
08:43PTR-ToF-MS Coupled with an Automated Sampling System and Tailored Data Analysis for Food Studies: Bioprocess Monitoring, Screening and Nose-space Analysis
Published on: May 11, 2017
08:03A Tandem Liquid Chromatography–Mass Spectrometry-based Approach for Metabolite Analysis of Staphylococcus aureus
Published on: March 28, 2017
Related Concept Videos
Development of Analytical Methods
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
Data Validation
Key parameters for method validation include:
Quantitative Analysis
In quantitative analysis, two key measurements are made: the sample quantity and a property proportional to the amount of the analyte (the substance being analyzed). This forms the basis of the method...
Therapeutic Drug Monitoring: Drug Analysis Methods
Qualitative Analysis
There are two main approaches to qualitative analysis:...