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

Bioanalysis. 2018 Nov 1;10(21):1723-1732. doi: 10.4155/bio-2018-0194. Epub 2018 Nov 6.

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.

MeSH terms

  • Animals
  • Chemistry Techniques, Analytical / methods
  • Chemistry Techniques, Analytical / standards
  • Drug Development* / methods
  • Drug Development* / standards
  • Drug Industry* / methods
  • Drug Industry* / standards
  • Europe
  • Humans
  • Pharmacokinetics
  • Quality Control*
  • Reproducibility of Results*
  • Toxicity Tests / methods
  • Toxicity Tests / standards
  • Validation Studies as Topic