Our scientists utilize effective method development, transfer, set-up, and validation techniques to identify, separate, and quantitate drug and metabolites in biological fluids. We provide the following method based services.
Method Development
- Reverse engineering and rapid transition between species as well as matrices
- Equipment selection based on molecule and sensitivity requirements, e.g., LC-MS-MS or ELISA kits
- Selection of proper sample preparation technique
- Instrument optimization for relevant parameters, e.g., mass spectrometer ionization
- Considerations for target curve range, Cmax, Tmax, AUC as requested or published
- Identification of an appropriate blank matrix, anticoagulant, reference standard, and stable labeled internal standard as applicable
- Ensuring analyte stability under sample handling conditions, and using stabilizer if necessary
Method Transfer, Set-up, and Cross-Validation
- Qualification and transfer from another laboratory or to new equipment/analyst within the same laboratory
- Modification due to unsuccessful transfer due to incomplete or incorrect information
- Adjustments of equipment conditions for robustness and straightforward method validation downstream
- Preparation of calibration standards and quality control samples as well as performing a test run
- Cross-validation using unknown quality control samples and incurred samples
Method Validation
- Fit for purpose full three-day LC-MS-MS or six-day ELISA based validation as per FDA guidance
- Assessment of method selectivity, specificity, sensitivity, precision, and accuracy
- Process stability including, short term bench top, autosampler, and freeze-thaw
- Examination of extraction recovery, carryover, matrix effect, matrix suppression, and other relevant parameters
- Stability assessment of drugs and biomarkers during sample processing, analysis, and long term storage within biological matrices at various time points