PK sample analysis
SYRINX Bioanalytics has extensive experience of developing new methods using state-of-the-art immunological and cell based techniques for pharmacokinetic (PK) sample analysis.
SYRINX offers a multi-step approach for PK assay development and routine analysis. After each step a report is sent to the sponsor for evaluation.
Please send your enquiries here.
1) Feasibility study / Method development
A short feasibility study may be performed to assess different assay designs for the measurement of the drug in a biological matrix. Depending on the drug molecule in question and the prerequisites of the new method the following method development test are normally performed:
- Labeling of reagents
- Characterization of reagents
- Optimal reagent concentrations and incubation times
- Minimum required dilution (matrix effect)
- Calibration curve
- Dilutional linearity and hook effect
- Estimation of the lower/upper limit of quantification (LLOQ/ULOQ)
- Initial intra- and inter-assay precision and accuracy data
- Selectivity (recovery)
- Specificity (interference)
- Ruggedness and robustness
- Stability
2) Method validation (in GLP)
The chosen method may be further developed before it is finally validated for its intended purpose. The following parameters will be among those validated in GLP:
- Precision and accuracy
- Calibration curve and fitting parameters
- Sensitivity (LLOQ) and upper limit of quantification (ULOQ)
- Selectivity
- Specificity
- Dilutional linearity and parallelism
- Hook effect
- Ruggedness and robustness
- Stability
The list of parameters may vary depending on the underlying scientific or technical principles of the method used. The validation report is thoroughly reviewed by our QA-unit before it is sent to the sponsor for evaluation.
3) Bioanalytical studies (in GLP)
Preclinical or clinical study samples will be analyzed and results reported according to GLP guidelines using the validated methods.
