Analysis of Imprecision in Incurred Sample Reanalysis for Small Molecules

Over the years, incurred sample (IS) reanalysis (ISR) has become a tool to confirm the reliability of bioanalytical measurements. The recommendation for ISR acceptance criterion for small molecules is at least 67% of ISR samples that have reanalyzed concentrations within 20% of their original concen...

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Bibliographic Details
Published in:The AAPS journal 2015-01, Vol.17 (1), p.206-215
Main Authors: Subramaniam, Sriram, Patel, Devvrat, Davit, Barbara M., Conner, Dale P.
Format: Article
Language:English
Subjects:
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biotechnology
Chemistry Techniques, Analytical - methods
Computer Simulation
Pharmaceutical Preparations - analysis
Pharmacology/Toxicology
Pharmacy
Quality Control
Reproducibility of Results
Research Article
Sample Size
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Summary:Over the years, incurred sample (IS) reanalysis (ISR) has become a tool to confirm the reliability of bioanalytical measurements. The recommendation for ISR acceptance criterion for small molecules is at least 67% of ISR samples that have reanalyzed concentrations within 20% of their original concentrations when normalized to their means. To understand the relevance of the ISR acceptance criterion and sample size requirements, simulated ISR studies evaluated the probability of ISR studies passing the acceptance criterion (ISR pass rate) as a function of IS imprecision and sample size. When IS imprecision (percent coefficient of variation: %CV) is low (≤10 or 1–10% CV), high ISR pass rate (≥99%) is attained with
ISSN:1550-7416
1550-7416
DOI:10.1208/s12248-014-9689-1