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Incurred sample reproducibility: 10 years of experiences: Views and recommendations from the European Bioanalysis Forum

Kall, Morten A. and Michi, Marco and Van der Strate, Barry and Freisleben, Achim and Stoellner, Daniela and Timmerman, Philip (2018) Incurred sample reproducibility: 10 years of experiences: Views and recommendations from the European Bioanalysis Forum. Bioanalysis, 10 (21). pp. 1723-1732. ISSN 17576199

Abstract

With 10 years of experiences on incurred sample reanalysis (ISR) as an integrated part of regulated bioanalysis, the European Bioanalysis Forum has reflected on the implementation and the use of ISR. Three surveys were conducted in 2016 and 2017 as a revisit of the ISR experiences within European pharmaceutical industry and contract research organizations: has ISR become a tool for postvalidation and process check of a bioanalytical method performance and has ISR become a routine in our laboratories? Do we agree on the interpretation of guidelines/guidance and are we aligned in our approach - among others?

Item Type: Article
Keywords: European Bioanalysis Forum incurred sample reanalysis incurredsample reproducibility
Date Deposited: 01 Jan 2019 00:45
Last Modified: 01 Jan 2019 00:45
URI: https://oak.novartis.com/id/eprint/37305

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