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Scientific Poster
April 07, 2016

Unifying Processes to Measure Entecavir in Human Matrices in Two Geographically Distinct Laboratories

Transfer of an assay between Europe and North America
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

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. 

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