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Special Report

ISR: what have we learned after a decade of experience?

    Tom Verhaeghe

    *Author for correspondence:

    E-mail Address: TVERHAEG@its.jnj.com

    Development Bioanalysis, Janssen Research & Development, A division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

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    Published Online:10 Oct 2018https://doi.org/10.4155/bio-2018-0167

    Abstract

    Within our company, incurred sample reproducibility (ISR) was implemented a decade ago. Only 11 studies (<2%) with failed ISR were identified over that period. These cases are described along with the strategy followed to resolve the issue. For three studies the failing ISR was caused by a method failure and all instances could be traced back to an instability problem. The majority of the failed ISR experiments were due to human error. For most of the studies the issue could be resolved and results reported. In two studies, no valid results could be generated. Based on this analysis we advise to limit the number of studies that require ISR assessment.

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