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Editorial

Matrix Effects in Quantitative Bioanalytical Validations: are Reproducible Results All That is Necessary?

Pages 2739-2741 | Published online: 21 Nov 2013

References

  • Matuszewski BK , ConstanzerML, Chavez-EngCM. Matrix effect in quantitative LC–MS/MS analysis of biological fluids: a method for determination of finasteride in human plasma at pictogram per milliliter concentrations. Anal. Chem. 70, 882–889 (1998).
  • Shaw VP , MidhaKK, FindlayJWAet al. Bioanalytical method validation-a revisit with a decade of progress. Pharm. Res. 17(12), 1551–1557 (2000).
  • Viswanathan CT , BansalS, BoothBet al. Workshop/conference report-quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9(1 Article 4), E30 (2007).
  • US FDA . Guidance for Industry: Bioanalytical Method Validation. Department of Health and Human Services, Center for Drug Evaluation and Research, Rockville, MD, USA, September (2013).

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