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 journalEditorialAcademicpeer-review

4 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 languageEnglish
Pages (from-to)1723-1732
Number of pages10
JournalBioanalysis
Volume10
Issue number21
DOIs
Publication statusPublished - Nov-2018
Externally publishedYes

Keywords

  • European Bioanalysis Forum
  • incurred sample reanalysis
  • incurredsample reproducibility
  • VALIDATION
  • IMPLEMENTATION
  • REANALYSIS

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