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Surrogate matrix: opportunities and challenges for tissue sample analysis.

Stacy Ho1, Hong Gao2

  • 1Drug Metabolism & Pharmacokinetics, Disposition, Safety & Animal Research (DSAR), Sanofi, 153 Second Avenue, Waltham, MA 02451, USA.

Bioanalysis
|September 24, 2015
PubMed
Summary
This summary is machine-generated.

This study addresses challenges in using surrogate matrices for quantifying drugs and biomarkers when native tissue is scarce or contains endogenous compounds. It offers guidance on selecting, validating, and establishing robust surrogate tissue bioanalytical methods.

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Area of Science:

  • Bioanalytical Chemistry
  • Pharmacokinetics
  • Biomarker Analysis

Background:

  • Limited availability of native tissue matrices and endogenous analyte presence pose challenges for bioanalysis.
  • Surrogate matrices offer a viable alternative for quantitation of drugs, metabolites, and biomarkers in such scenarios.

Purpose of the Study:

  • To summarize and discuss challenges in selecting and validating surrogate matrices.
  • To outline the establishment of surrogate tissue bioanalytical methods using a fit-for-purpose approach.
  • To review current practices for evaluating key assay parameters and provide suggestions for method development.

Main Methods:

  • Systematic review of current practices for evaluating surrogate tissue assay parameters.
  • Discussion of challenges in surrogate matrix selection and validation.
  • Application of the fit-for-purpose approach for method establishment.

Main Results:

  • Identified key parameters for surrogate tissue assay evaluation: sensitivity, specificity, selectivity, interference, precision, accuracy, recovery, matrix effects, and stability.
  • Provided considerations and suggestions for overcoming challenges during method establishment and tissue sample analysis.

Conclusions:

  • Effective use of surrogate matrices requires careful selection, validation, and method development.
  • Addressing challenges in assay parameters is crucial for reliable bioanalytical results using surrogate tissues.
  • The fit-for-purpose approach aids in establishing suitable surrogate tissue bioanalytical methods.