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Co-medication and interference testing in bioanalysis: a European Bioanalysis Forum Recommendation

de Zwart, Marcel and Lausecker, Berthold and Globig, Susanne and Neddermann, Daniel and Le Bras, Bruno and Guenzi, Alberto and White, Stephen and Scheel-Fjording, Marianne and Timmerman, Philip (2016) Co-medication and interference testing in bioanalysis: a European Bioanalysis Forum Recommendation. Bioanalysis, 8 (19). pp. 2065-2070. ISSN 1757-6180

Abstract

Interference testing of co-medication in bioanalytical method validation has become an area of debate in view of the increased specificity offered by current state-of-the-art technology in both LC-MS/MS and ligand-binding assay (LBA) platforms. In view of this, and considering the extensive experience within the European Bioanalysis Forum member companies, we evaluated the impact of co-medication on the performance of hundreds of bioanalytical methods with the aim of providing a science based recommendation on how to evaluate and document potential interference from co-medication on the PK parameters in clinical studies in patients and volunteers

Item Type: Article
Date Deposited: 25 Sep 2016 00:45
Last Modified: 25 Sep 2016 00:45
URI: https://oak.novartis.com/id/eprint/30080

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