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

Morten Anders Kall; Marco Michi; Barry van der Strate; Achim Freisleben; Daniela Stoellner; Philip Timmerman

doi:10.4155/bio-2018-0194

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

Morten Anders Kall, Marco Michi, Barry van der Strate, Achim Freisleben, Daniela Stoellner, Philip Timmerman^*

^*Corresponding author for this work

Research output: Contribution to journal › Editorial › Academic › peer-review

17 Citations (Scopus)

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?

Original language	English
Pages (from-to)	1723-1732
Number of pages	10
Journal	Bioanalysis
Volume	10
Issue number	21
DOIs	https://doi.org/10.4155/bio-2018-0194
Publication status	Published - Nov-2018
Externally published	Yes

Keywords

European Bioanalysis Forum
incurred sample reanalysis
incurredsample reproducibility
VALIDATION
IMPLEMENTATION
REANALYSIS

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title = "Incurred sample reproducibility: 10 years of experiences: views and recommendations from the European Bioanalysis Forum",

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?",

keywords = "European Bioanalysis Forum, incurred sample reanalysis, incurredsample reproducibility, VALIDATION, IMPLEMENTATION, REANALYSIS",

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year = "2018",

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AU - Kall, Morten Anders

AU - Michi, Marco

AU - van der Strate, Barry

AU - Freisleben, Achim

AU - Stoellner, Daniela

AU - Timmerman, Philip

PY - 2018/11

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AB - 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?

KW - European Bioanalysis Forum

KW - incurred sample reanalysis

KW - incurredsample reproducibility

KW - VALIDATION

KW - IMPLEMENTATION

KW - REANALYSIS

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EP - 1732

JO - Bioanalysis

JF - Bioanalysis

IS - 21

ER -

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

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Keywords

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