Analytical validation is a key step for each of our projects. We operate under strict GLP/GCLP/GMP compliance during the testing of samples.
- Validation plan
- Parameters for evaluation: accuracy, specificity, sensitivity, working range (detection limits), reproducibility, linearity, robustness, stability
- Precision: repeatability, intermediate precision
- Determination of working range, upper & lower limit of quantification
- 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
- Draft USP <1033>