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Related Concept Videos

Inductively Coupled Plasma-Mass Spectrometry (ICP-MS): Interferences01:20

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Inductively coupled plasma–mass spectrometry (ICP–MS) is a highly selective and sensitive technique for accurate elemental analysis. Though the analysis of ICP–MS mass spectra is comparatively straightforward, it is affected by spectroscopic and non-spectroscopic interferences. Spectroscopic interferences arise when the plasma contains ionic species with an m/z value the same as the analyte ion. Spectroscopic interference can be categorized as isobaric, polyatomic ions, and refractory oxide ion...
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Related Experiment Video

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Biomolecular Detection employing the Interferometric Reflectance Imaging Sensor (IRIS)
11:04

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Published on: May 3, 2011

Incurred sample reanalysis (ISR): a decisive tool in bioanalytical research.

Manish Yadav1, Pranav S Shrivastav

  • 1Bioequivalence and Bioanalytical Department, Cadila Pharmaceuticals Ltd., Ahmedabad, India. manish.yadav@cadilapharma.co.in

Bioanalysis
|May 7, 2011
PubMed
Summary

Incurred sample reanalysis (ISR) is crucial for assay reproducibility in bioanalysis. This study details troubleshooting five common issues encountered with incurred samples to improve method reliability.

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Analytical Chemistry
  • Bioanalytical Method Development

Background:

  • Incurred sample reanalysis (ISR) is essential for validating bioanalytical methods, ensuring assay reproducibility with real-world study samples.
  • Incurred samples possess complex matrices that differ from calibration standards, necessitating careful analysis.
  • The 2008 AAPS Workshop highlighted ISR as a mandatory step in Good Laboratory Practice (GLP) bioanalysis.

Purpose of the Study:

  • To summarize five troubleshooting cases encountered during incurred sample analysis in a bioanalytical laboratory.
  • To identify common issues affecting assay reproducibility with incurred samples.
  • To provide data-supported solutions for improving bioanalytical method reliability.

Main Methods:

  • Analysis of incurred samples for mesalamine, hydrochlorothiazide, clopidogrel, sildenafil, and rabeprazole using developed bioanalytical methods.
  • Troubleshooting specific issues including sample inhomogeneity, processing errors, buffer pH effects, metabolite instability, and environmental changes.
  • Detailed documentation of corrective actions and supporting data for each case.

Main Results:

  • Identified key issues impacting incurred sample analysis: sample inhomogeneity, errors in sample processing, buffer pH effects, metabolite instability, and laboratory environment variations.
  • Successfully traced and corrected these incidents through systematic investigation and data analysis.
  • Demonstrated the impact of these issues on assay reproducibility.

Conclusions:

  • Troubleshooting incurred sample analysis is critical for ensuring the reliability of bioanalytical methods.
  • Addressing issues like sample inhomogeneity and matrix effects enhances assay accuracy.
  • This investigation underscores the significance of ISR in developing robust and efficient bioanalytical methods for drug development.