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White Paper – incurred sample reproducibility: 10 years of experience and recommendations from the EBF

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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, incurred sample reproducibility


Incurred sample reanalysis (ISR) was, in its current form, introduced at the AAPS Spring Workshop in Crystal City, 1–3 May 2006 (CC III) and the recommendations were later published in 2007 [1]. This CC III White Paper was rapidly followed by several publications; Fast et al. [2], the EBF ISR recommendations [3] and recommendations from the third Calibration and Validation Group Workshop [4]. Later, these publications were followed up by the European Medicines Agency (EMA) guideline (EMEA/CHMP/EWP/192217/2009) to be effective in 2011 (rev #1 corr. 2 from 2015) [5]. The draft US FDA guidance to industry was published in 2013 [6], followed in 2014 by the Crystal City V report [7], recommendations from the Global Bioanalysis Consortium [8] and Japanese Ministry of Health, Labour and Welfare (MHLW) Guideline on Bioanalytical Method Validation in Pharmaceutical Development [9].

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1 Viswanathan CT, Bansal S, Booth B et al. Workshop/conference report – quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand-binding assays. AAPS J. 9(1), E30–E42 (2007).

2 Fast DM, Kelly M, Viswanathan C et al. AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples – implications of crystal city recommendations. AAPS J. 11(2), 238–241 (2009).

3 Timmerman P, Luedtke S, van Amsterdam P et al. Incurred sample reproducibility views and recommendations by European Bioanalytical Forum. Bioanalysis 1(6), 1049–1056 (2009).

4 Savoie N, Garofolo F, van Amsterdam P et al. 2009 white paper on recent issues in regulated bioanalysis from the 3rd calibration and validation group workshop. Bioanalysis 2(1), 53–68 (2010).

5 EMA, European Medicines Agency. Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009 (2011). https://www.ema.europa.eu/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf.

6 US FDA, US Department of Health and Human Services. Draft guidance for industry: bioanalytical method validation (2013). http://academy.gmp-compliance.org/guidemgr/files/UCM368107.PDF.

7 Booth B, Arnold ME, DeSilva B et al. Workshop report: Crystal City V – quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance. AAPS J. 17(2), 277–288 (2015).

8 Fluhler E, Vazvaei F, Singhal P et al. Repeat analysis and incurred reanalysis: recommendations for best practices and Harmonisation from the Global Bioanalysis Consortium Harmonisation team. AAPS J. 16(6), 1167–1174 (2014).

9 Japanese Ministry of Health, Labour and Welfare. Guideline on bioanalytical method validation in pharmaceutical development. MHLW, Japan (2013). http://www.nihs.go.jp/drug/BMV/250913_BMV-GL_E.pdf.

10 US FDA. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research. Rockville, MD, USA (2018). https://www.fda.gov/downloads/drugs/guidances/ucm070107.Pdf

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