Unifying Processes to Measure Entecavir in Human Matrices

Transfer of an assay between Europe and North America

Presented at the 2015 European Bioanalysis Forum this poster details our efforts to transfer an assay between labs.  We often receive requests for one-off studies requiring analysis of compounds that are not in the Sponsor’s pipeline. These may be in support of drug interaction, comparator, or co administration studies. In this case, sensitive assays were required for the measurement of entecavir in human plasma and human urine. Although the clinical study was to be supported in North America, there was capacity for assay development activities in Europe. This was used as an opportunity to test how transferrable an assay could be between the two facilities. The development and validation were performed in Oss with a partial validation and subsequent sample analysis in Ithaca, New York. 

Q2 Solutions offers complete bioanalytical and ADME solutions for testing around the globe and across the product development spectrum.  We combine knowledge from the collective services provided by our central labs, bioanalytical and ADME labs network, as well as integration into Quintiles global early clinical Phase I unit. The result is timely, high-quality, regulatory compliant data that supplies the insights you need to make more informed decisions and instill confidence in your regulatory filings.

Authors: Benno Ingelse, Diep Vu-Pham, Karlien Schellekens, Elsa Artola, Christopher W. Binns, Erika L. Clendenning, Rachel L. Caminiti, Martin M. Rappleyea and John R. Perkins

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