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Bioanalytical method validation

Aim:

To validate a method for the quantification of the test item and/or its metabolite(s) in biological matrices.

Procedure:

Procedure is performed according to the valid bioanalytical method validation guidelines:

  • EMEA/CHMP/EWP/192217/2009), July 2011
  • FDA/CDER/CVM, May 2001

Investigated (for LC/MS/MS):

  • Selectivity for analytes and internal standard (IST)
  • Selectivity for matrix
  • Linearity
  • Intra-day and inter-day accuracy and precision
  • Sensitivity (Lower limit of quantification)
  • Recovery
  • Matrix effect
  • Stability in solution
  • Stability in processed sample: autoinjector and re-injection stability
  • Stability in matrix:
  • Short -term stability
  • Freeze and thaw stability
  • Long-term stability in frozen matrix
  • Hemolysis effect
  • Dilution effect
  • Effect of high lipid content, if relevant

 

Evaluation:

GLP compliant full validation report.

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