A decade of incurred sample reanalysis: failures, investigations and impact

Author:

Lee Lisa B1,Wickremsinhe Enaksha R1

Affiliation:

1. Lilly Research Laboratories, Eli Lilly & Company, Lilly Corporate Center Indianapolis, IN 46285, USA

Abstract

Incurred sample reanalysis (ISR) is used to ensure the validity and reliability of bioanalytical data. Additionally, ISR results also help identify issues that could influence or bias the data. Overall, based on a decade of experimental data generated at Eli Lilly and Company, ISR failures are few with less than 5% of ISR samples failing to meet acceptance criteria. In a majority of situations, the cause for ISR failures has been ‘human-error.’ However, there are examples where ISR has helped identify issues related to the stability of the analyte or the ruggedness of the method. As a strategy, it is beneficial to conduct ISR following the completion of a few sample runs, so any potential issues impacting the validity and reliability of the data can be identified and rectified early.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference16 articles.

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3. EMA. Guideline on bioanalytical method validation (2011). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.

4. FDA. Bioanalytical method validation. Guidance for Industry (2018). https://www.fda.gov/downloads/drugs/guidances/ucm070107.Pdf.

5. Confirmatory reanalysis of incurred bioanalytical samples

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