Assay Development and Qualification

Analytical validation is a key step for each of our projects. We operate under strict GLP/GCLP/GMP compliance during the testing of samples.

Test Validation

  • Validation plan
  • Parameters for evaluation: accuracy, specificity, sensitivity, working range (detection limits), reproducibility, linearity, robustness, stability
  • Precision: repeatability, intermediate precision
  • Accuracy
  • Determination of working range, upper & lower limit of quantification
  • Recovery
  • Linearity
  • Sample stability (freeze-thaw, long/short term)
  • Selectivity, specificity
  • Validation report

Texcell will propose a validation package adapted to your needs, taking into account your drug development phase, GLP compliance, and (pre)clinical study status as a primary or secondary objective for instance.

Main Bioanalytical Validation Guidelines

  • ICH Q2R1
  • FDA Guidance “Bioanalytical Method Validation” (rev1, 2013)
  • EMA Guideline on Bioanalytical Method Validation EMA/CHMP/EWP/192217/2009 (2011)
  • Draft USP <1033>